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Biomedical subjects

I Caruso

Publications and source records attributed to I Caruso.

At least 19 recordsLinked to original sources
PubMed2004

A method for positioning electrodes during surface EMG recordings in lower limb muscles.

PURPOSE: The aim of this work is to provide information about the degree of inter-subject uniformity of location of innervation zone (IZ) in 13 superficial muscles of the lower limb. The availability of such information will allow researchers to standardize and optimize their electrode positioning procedure and to obtain accurate and repeatable estimates of surface electromyography (sEMG) signal amplitude, spectral variables and muscle fiber conduction velocity. METHODS: Surface EMG signals from gluteus maximus, gluteus medius, tensor faciae latae, biceps femoris, semitendinosus, vastus medialis obliquus, vastus lateralis, rectus femoris, tibialis anterior, peroneus longus, soleus, gastrocnemius medialis and lateralis muscles of ten healthy male subjects aged between 25 and 34 years (average = 29.2 years, S.D. = 2.5 years) were recorded to assess individual IZ location and signal quality. RESULTS: Tensor faciae latae, biceps femoris, semitendinosus, vastus lateralis, gastrocnemius medialis and lateralis showed a high level of both signal quality and IZ location uniformity. In contrast, rectus femoris, gluteus medius and peroneus longus were found to show poor results for both indexes. Gluteus maximus, vastus medialis obliquus and tibialis anterior were found to show high signal quality but low IZ location uniformity. Finally, soleus muscle was found to show low signal quality but high IZ location uniformity. CONCLUSIONS: This study identifies optimal electrode sites for muscles in the lower extremity by providing a standard landmarking technique for the localization of the IZ of each muscle so that surface EMG electrodes can be properly positioned between the IZ and a tendon.

Adult↗
PubMed2004

Surface EMG alterations induced by underwater recording.

BACKGROUND AND PURPOSE: This study aims to verify if amplitude and spectral characteristics of surface EMG signal are modified due to recording in a wet environment. METHODS: Isometric contractions of the biceps brachii muscle of ten subjects were performed in several different set-up combinations, both in dry (D) and in water from hydrotherapy pools (PW), with (PWM) or without moving the pool water and with (T) or without water-resistant adhesive taping. RESULTS: In PW condition the amplitude of the recorded signal is reduced to 5-10% of the corresponding signal recorded in D condition. In PWM the power spectrum is drastically reduced and altered by the water movement that introduces an increase of spectral power in the frequency range 0-20 Hz. The use of T modality allows to record signals with both amplitude and spectral frequencies comparable with those obtained in the D conditions. DISCUSSION AND CONCLUSION: This work demonstrates the need for water resistant taping when EMG signals are recorded in water. Signals recorded without such a protective film are strongly affected in their amplitude and frequency characteristics by the conductivity and the movement of water.

Adult↗
PubMed2002

Bioelectrical impedance measures in different position and vs dual-energy X-ray absorptiometry (DXA).

BACKGROUND: Bioelectrical impedance analysis (BIA) is a safe, low-cost, non-invasive, rapid method for the assessment of body composition. It has therefore a great potential to be employed for epidemiological and clinical studies. However, many devices are available to estimate total body water (TBW), fat-free mass (FFM) and fat mass (FM) by bioelectrical impedance measurements. Moreover, bipedal devices allowing measurements in the only standing position are recently developed. They are easy and practical to use without operator, so a large diffusion can be forecasted in fields as sport and diet programs. Comparison of body composition estimation by a bipedal device with bioimpedance devices currently used, using dual-energy X-ray absorptiometry (DXA) as reference method. METHODS: The study was performed on 18 healthy women volunteers, age 32.0+/-10.7 years divided in two groups at different levels of body fatness. A Xitron 4000 impedance analyser, a BIA-101 RJL System, and the bipedal device Tanita were used for comparison. The measurements were performed in standing and supine position for Xitron and RJL devices. DXA measurements were performed with a total body scanner DPX, Lunar. RESULTS: FM and FFM were not statistically different when measured with Xitron and RJL in comparison with DXA, while these variables were significantly different between Tanita and DXA measurements. No significant difference were found between measurements in the supine and standing position with the Xitron and RJL system. CONCLUSIONS: Our results suggest that FM and FFM evaluated by bipedal device Tanita are significantly different from FM and FFM measured by DXA in both normal and obese population.

Absorptiometry, Photon↗
PubMed2001

The role of NSAIDs in psoriatic arthritis: evidence from a controlled study with nimesulide.

OBJECTIVE: To define the optimal dose of nimesulide (NIM) for treating psoriatic arthritis. METHODS: Eighty patients entered a 4-week, double-dummy, randomised, controlled study. Each patient was allocated to one of the following treatment groups: NIM 100 mg/day, NIM 200 mg/day, NIM 400 mg/day, or placebo. Primary end points for arthritis assessment were the scores for tender and swollen joints, and the physician's and patient's global assessment of efficacy. RESULTS: 76/80 patients completed the study. NIM decreased the score for tender and swollen joints from baseline to the end swollen joints from baseline to the end of therapy (p < 0.05). Pain severity on a visual analogue scale (VAS) was reduced by NIM 200 mg (p = 0.03) or NIM 400 mg (p = 0.019) compared to placebo, as was morning stiffness (p = 0.038 and p = 0.008, respectively), but the trends with 100 mg were not statistically significant. The investigators and patients assessed the global efficacy of the NIM 200 and 400 mg/day groups as better than placebo or NIM 100 mg. Side effects were observed in 12 patients (15%) during treatment. They were mostly mild, only one patient withdrew from the study as a result, and the trend for a higher incidence with NIM was not statistically significant. The Psoriasis Area Severity Index (PASI) and the ESR did not show any significant changes. Patients in the placebo group took more paracetamol per day compared with those in the NIM groups (p = 0.007). CONCLUSIONS: Nimesulide 200 and 400 mg/day are effective and safe in psoriatic arthritis.

Abdominal Pain↗
PubMed2000

Ion-pairing high-performance liquid chromatographic method for the detection of N-acetylaspartate and N-acetylglutamate in cerebral tissue extracts.

An ion-pairing high-performance liquid chromatographic method for the determination of N-acetylaspartate and N-acetylglutamate using a C-18 column and a UV detection at 210 nm wavelength, by means of a diode array detector, is presented. A buffer containing 2.8 mM tetrabutylammonium hydroxide, 25 mM KH(2)PO(4), 1.25% methanol, pH 7. 00, is utilized for the isocratic separation of these N-acetylated amino acids, at a flow rate of 1 ml/min and a column temperature of 23 degrees C. The suitability of this chromatographic separation (without additional chromatographic steps prior to HPLC assay) to monitor variations both of N-acetylaspartate and of N-acetylglutamate in perchloric acid brain extracts from rats subjected to the impact acceleration model of diffuse brain injury is also reported. According to the data presented, this HPLC method allows the separation of the two N-acetylated amino acids considered from the many possible interfering compounds, commonly present in extracts of cerebral tissue, which have high extinction coefficients at 210 nm wavelength. Values of N-acetylaspartate and N-acetylglutamate determined by this method showed that cerebral trauma negatively affects both compounds, according to the severity of trauma itself.

Animals↗
PubMed2000

Geometrical factors in surface EMG of the vastus medialis and lateralis muscles.

Surface EMG signals detected in dynamic conditions are affected by a number of artefacts. Among them geometrical factors play an important role. During movement the muscle slides with respect to the skin because of the variation of its length. Such a shift can considerably modify sEMG amplitude. The purpose of this work is to assess geometrical artefacts on sEMG during isometric contractions at different muscle lengths. The average rectified value (ARV) of 15 single differential signals was obtained by means of a linear array of 16 bar electrodes from the vastus medialis and lateralis muscles. The knee angle was changed from 75 degrees to 165 degrees in steps of 30 degrees and voluntary isometric contractions at a low, medium and high force level were performed for each angle. The ARV pattern was normalized with respect to the mean activity to compare signals from different joint angles. From the data collected it was possible to separate the geometrical changes from the changes due to different intensities of activation. In three out of five subjects, we found (within the resolution of our measures) a 1 cm shift for the vastus medialis muscle while no shift was observed for the other two subjects. For the vastus lateralis muscle a 1 cm shift was found in two out of four subjects. Such a shift produces the main contribution to geometrical artefacts. To avoid such artefacts the innervation zones should be located and the EMG electrodes should not be placed near them.

Adult↗
PubMed1998

Peptic ulcer therapy with cimetidine versus tripotassium dicitrato bismuthate in rheumatoid arthritis patients undergoing chronic NSAID treatment.

AIM: To compare the efficacy of cimetidine and tripotassium dicitrato bismuthate (TDB) in arthritic patients who had developed gastric (GU) or duodenal (DU) ulceration while taking non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: Eighty-six rheumatoid arthritis (RA) patients affected by endoscopically proven DU (n = 44) or GU (n = 42), and on chronic NSAID therapy which was not suspended during anti-ulcer therapy, were randomized to cimetidine (400 mg t.d.s.) or TDB (120 mg q.d.s.). A repeat endoscopy was planned after 4 weeks (and 8 weeks, in case of failed healing). The patients who were unhealed after 8 weeks of therapy were allocated to the alternative anti-ulcer drug for a further 8 weeks without interrupting the anti-inflammatory therapy. RESULTS: At week 4 of therapy. 14/24 (58%) DU and 9/20 (45%) GU patients treated with cimetidine were healed, compared with 12/20 (60%) and 10/22 (45%) TDB-treated patients (N.S.). At week 8 of therapy, the DU healing rates were 15/24 (63%) with cimetidine and 14/20 (70%) for TDB. The corresponding GU healing rates were 12/20 (60%) with cimetidine and 13/22 (60%) for TDB (N.S.). At week 16, complete healing with cimetidine was observed in 67% of DU and 57% of GU patients unhealed with TDB; the corresponding figures in the patients crossed to TDB were 83% for DU and 63% for GU patients (N.S. vs. cimetidine). CONCLUSIONS: No statistically significant difference was found between the healing activities of cimetidine and TDB in rheumatoid arthritis patients with peptic ulcer who did not interrupt their NSAID treatment for arthritis. This trial showed that the continued consumption of NSAIDs appears to slow the ulcer healing process, especially in GU patients.

Administration, Oral↗
PubMed1998

Prevention of gastroduodenal damage with omeprazole in patients receiving continuous NSAIDs treatment. A double blind placebo controlled study.

AIM: The aim of this study was to compare omeprazole (20 mg once daily) with placebo in the long-term prevention of gastroduodenal lesions induced by indomethacin, diclofenac and ketoprofen. PATIENTS AND METHODS: 114 patients with arthritic disorders and requiring indomethacin, diclofenac or ketoprofen were randomized in a double blind manner to receive omeprazole-20 mg once daily- or identical placebo for three weeks. The gastroduodenal mucosa damage was scored according to a 0-4 point endoscopic scale. RESULTS: Of the 114 patients, 103 (50 in the omeprazole group, 53 in the placebo group) were submitted to endoscopy, while 11 patients dropped out for non-medical reasons. At the final endoscopy, 26/57 (46%) of omeprazole group, and 20/57 (35%) of the placebo group had normal gastroduodenal mucosa (score = 0) (p ns; 95% IC -0.073 + 0.284). A gastric ulcer was observed in 7/57 (12%) patients, all in the placebo group (p < 0.01 vs omeprazole); 2 patients (1 in the omeprazole group and 1 in the placebo group) developed a duodenal ulcer. Dyspeptic symptoms developed in 10% of the patients treated with omeprazole and 29% of those receiving placebo (p ns). CONCLUSIONS: Omeprazole, 20 mg once daily, provides effective prophylactic therapy in patients at risk of developing NSAID-associated gastric and duodenal ulcer.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1997

Effects of isokinetic, isotonic and isometric submaximal exercise on heart rate and blood pressure.

The purpose of the present study was to compare arterial pressure (AP) and heart rate (HR) responses to submaximal isokinetic, isotonic and isometric exercises currently employed in physical rehabilitation therapy in terms of both magnitude and time-course. To this aim AP and HR were continuously and noninvasively measured in ten healthy subjects performing isokinetic, isotonic and isometric exercises at the same relative intensity. Isokinetic and isotonic exercises consisted of 30 knee extension/flexion repetitions at 40% of maximal effort. Isokinetic speed was set at 180 degrees s(-1). Isometric exercise consisted of a 60-s knee extension at 40% maximal voluntary contraction. The AP showed a rapid and marked increase from the onset of all types of exercise progressing throughout the exercises. Peak systolic (SAP) and diastolic (DAP) arterial pressure were 190.7 (SEM 8.9) and 121.6 (SEM 7.8) mmHg during isokinetic and 197.6 (SEM 11.2) and 128.3 (SEM 7.7) mmHg during isotonic exercise, respectively. During isometric exercise peak SAP and DAP were 168.1 (SEM 6.3) and 102.1 (SEM 3.7) mmHg, respectively [both lower compared to isokinetic and isotonic exercise (P < 0.05)]. The HR rose abruptly and after five isokinetic and isotonic repetitions it had already increased by about 30 beats min(-1), continuing to rise throughout the exercises. The HR response to isometric exercise was significantly less (P < 0.05) at all times. An immediate fall in AP, undershooting resting levels, was observed at the cessation of all types of exercise, being more marked after isokinetic and isotonic exercise. These results indicate that submaximal exercise of a dynamic type induces greater AP responses than intensity-matched isometric exercise and that even submaximal endurance-type rehabilitation exercise yields an elevated functional stress on the cardiovascular system which could precipitate hazardous events particularly in subjects with unrecognized cardiac diseases.

Adult↗
PubMed1996

Role of Helicobacter pylori in ulcer healing and recurrence of gastric and duodenal ulcers in longterm NSAID users. Response to omeprazole dual therapy.

BACKGROUND: The relation between Helicobacter pylori infection and non-steroidal anti-inflammatory drug (NSAID)-associated peptic ulcers remains unclear; in particular, it is not known whether H pylori plays a part in the healing and recurrence of these ulcers. AIMS: To evaluate prospectively in a consecutive series of arthritis patients receiving longterm NSAID treatment the prevalence of peptic ulcer as well as the effect of H pylori eradication on the healing and recurrence of gastric and duodenal ulcer found. PATIENTS: Some 278 consecutive patients underwent gastroscopy with multiple biopsies of the gastric antrum and corpus for histological examination and rapid urease test. One hundred peptic ulcers (59 gastric ulcers, 39 duodenal ulcers, and two gastric ulcers concomitant with a duodenal ulcer) were found. Seventy per cent of these ulcers were H pylori positive. METHODS: According to their H pylori status, ulcer patients were randomised to one of the following treatments: H pylori negative ulcers received omeprazole 20 mg twice daily for four to eight weeks, whereas H pylori positive lesions were treated with omeprazole 20 mg twice daily plus amoxycillin 1 g twice daily (the second of these for the first two weeks) or omeprazole alone for four to eight weeks while continuing NSAID therapy. Patients with healed ulcers were endoscopically followed up for six months after stopping antiulcer therapy while continuing NSAIDs. RESULTS: Endoscopic healing rates for gastric and duodenal ulcers in the three different groups were similar both at four and eight weeks. H pylori eradication did not influence healing, which occurred in 14 of 20 (70%) of patients in whom H pylori was eradicated, compared with 14 of 17 (82%) of patients with persistent infection. Cumulative recurrence rates at six months did not statistically differ among the three different groups (27% in H pylori negative, 46% in H pylori positive, and 31% in those where H pylori was eradicated during the healing phase), although a numerical trend in favour of a higher recurrence rate in infected patients was evident. CONCLUSIONS: H pylori eradication does not confer any significant advantage on the healing of gastric and duodenal ulcers associated with longterm NSAID use. It remains to be established with certainty whether eradication may be helpful in the reduction of recurrence in a specific subset of NSAID associated ulcer.

Amoxicillin↗
PubMed1996

Endoscopic assessment of the effects of dipyrone (metamizol) in comparison to paracetamol and placebo on the gastric and duodenal mucosa of healthy adult volunteers.

The potentially damaging gastric and duodenal effects of dipyrone, a nonnarcotic analgesic agent, were evaluated in three phases in comparison to placebo and paracetamol. Three groups of 12 healthy adult volunteers were treated in a double-blind study, according to a cross-over, randomization sequence, using the double-dummy technique, for two 15-day periods, with dipyrone 3 g/day and placebo (group I), dipyrone 1.5 g/day and placebo (group II), and dipyrone 1.5 g/day and paracetamol 1.5 g/day (group III). An esophagogastroduodenoscopy was performed at the beginning and end of each treatment period. In the first treatment group, grade-3 and 4 mucosal lesions were found after dipyrone administration (3 g/day) in 3 of 12 (25%) subjects (multiple antral erosions, gastric ulcer and duodenal ulcer, 1 case each), whereas grade-2 mucosal lesions (antral erosions) were detected in 1 of 12 cases (8%) after the corresponding placebo treatment. The difference between the two treatments, however, was not statistically significant (p > 0.05). Only in the gastric ulcer case were subjective symptoms reported (feeling of hunger). At the 1.5-g/day dose (groups II and III), dipyrone produced no gastroduodenal lesions, the endoscopic results showing no appreciable difference between dipyrone and either placebo (p = 0.54) or paracetamol (p = 0.99). No subjective symptoms were reported in any of these subjects. Dipyrone, administered for 2 weeks, has effects on the gastric and duodenal mucosa comparable to those of paracetamol and placebo, though noticeable damage is detectable at a dosage of 3 g/day.

Acetaminophen↗
PubMed1995

Effects of oral alendronate and intranasal salmon calcitonin on bone mass and biochemical markers of bone turnover in postmenopausal women with osteoporosis.

The main objective of this study was to determine the effect of daily oral alendronate treatment on bone mass in postmenopausal women affected by osteoporosis. The efficacy of intranasal salmon calcitonin was also examined. Nine centers in Italy enrolled 286 postmenopausal women between the ages of 48 and 76 with spinal bone mineral density > or = 2 SD below adult mean peak in the two-year, double-blind, randomized, placebo-controlled trial. Patients were randomized to one of four treatment arms: double-blind placebo, alendronate 10 mg/day, alendronate 20 mg/day, or open-label intranasal salmon calcitonin 100 IU/day; all patients received 500 mg Ca++ supplements. Bone mass was measured by dual-energy x-ray absorptiometry every six months for two years. Patients who received alendronate 10 or 20 mg experienced significant increases in bone mass at all sites measured. At the end of the second year, the mean percent changes, for alendronate 10 and 20 mg relative to placebo, were 5.2% and 7.3% at the lumbar spine, 3.8% and 4.6% at the femoral neck, and 7.1% and 7.5% at the trochanter, respectively. In contrast, intranasal salmon calcitonin failed to increase bone mineral mass significantly at any site. Both alendronate doses significantly decreased serum alkaline phosphatase, serum osteocalcin, and urinary pyridinolines, markers of bone turnover, whereas placebo and intranasal calcitonin did not. Alendronate was generally well tolerated and no serious adverse events were attributed to its use.(ABSTRACT TRUNCATED AT 250 WORDS)

Absorptiometry, Photon↗
PubMed1995

Gastroduodenal tolerability of nabumetone versus naproxen in the treatment of rheumatic patients.

OBJECTIVE: The objective of this endoscopic, double-blind study was to evaluate the gastric tolerability of nabumetone, a novel nonsteroidal anti-inflammatory drug, compared with naproxen in patients with rheumatoid arthritis. METHODS: Patients with definite or classic rheumatoid arthritis as defined by ACR criteria were eligible for entry into the study if an initial endoscopy was normal or showed the presence of only one erosion or one or two submucosal hemorrhages. After a 7-day washout period, the patients were randomized to receive either nabumetone, 1 g, or naproxen, 500 mg, b.i.d. Blinding was achieved by the use of double dummies. Endoscopy was repeated after 4 wk of treatment. The primary efficacy parameters were Ritchie articular index, duration of morning stiffness, and global assessments. RESULTS: Gastric mucosal lesions of different degrees were observed in 9% (2/22) of nabumetone-treated patients and in 40% (12/30) of those who received naproxen (p = 0.01). One duodenal ulcer was found in a patient treated with nabumetone, and this patient had a history of duodenal ulcer. In the naproxen group, six patients were found to have an ulcer. Clinical evaluation of rheumatological symptomatology showed no statistical difference in relieving symptoms between the two drugs in the primary efficacy assessments. However, six nabumetone-treated patients dropped out because of lack of efficacy, compared with one in the naproxen group. Side effects were noted in three patients treated with nabumetone and in 14 treated with naproxen (p = 0.004). CONCLUSION: This study showed that nabumetone, 1 g daily, results in significantly less deterioration of gastric mucosa than naproxen, 500 mg daily, but the efficacy of naproxen, 1 g, appears to be more than that achieved with nabumetone, 1 g.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1994

A comparison of severe gastric damage as a result of pirprofen and naproxen treatment in rheumatoid arthritis: a controlled endoscopic study.

OBJECTIVE: The aim of this controlled endoscopic study was to compare the therapeutic efficacy and the gastric tolerance of two nonsteroidal anti-inflammatory drugs, pirprofen versus naproxen. DESIGN: A randomized endoscopic double-blind double-dummy study. SETTING: The gastrointestinal unit of a teaching hospital. SUBJECTS: Forty patients suffering from rheumatoid arthritis were enrolled. After an initial upper gastrointestinal endoscopy to rule out the presence of gastric mucosal lesions, the patients were randomly allocated in a double-blind, double-dummy manner, to receive either pirprofen (400 mg t.i.d.) or naproxen (500 mg b.i.d.) for 4 weeks; endoscopic control followed this treatment period, or was anticipated in the event of painful dyspepsia. INTERVENTIONS: Endoscopy at the beginning of the study and at 4 weeks, or anticipated in the event of painful dyspepsia. MAIN OUTCOME MEASURES: Primary outcome measure of the study was the possibility that pirprofen was less toxic to the gastric mucosa than naproxen, and at least as effective. RESULTS: Both drugs proved effective in relieving clinical symptoms, without a statistically significant difference. Gastric mucosa lesions were observed in 90% of pirprofen-treated patients and in 60% of those on naproxen (P = 0.03). The most severe lesions (grades 3 and 4) were found in 65% of subjects treated with pirprofen, as opposed to 15% of those treated with naproxen (P = 0.001). CONCLUSIONS: This study shows that pirprofen is at least as active as naproxen in relieving rheumatic symptoms, but its administration results in a significantly severe degree of gastric damage.

Adult↗
PubMed1994

Rehabilitation of walking with electromyographic biofeedback in foot-drop after stroke.

BACKGROUND AND PURPOSE: Alterations of gait cycle and foot-drop on the paretic limb are characteristic of stroke patients. Electromyographic biofeedback treatment has been used in rehabilitation of walking, but results are controversial. We performed gait analysis to evaluate the efficacy of electromyographic biofeedback compared with physical therapy. METHODS: Sixteen patients with ischemic stroke were enrolled in the study. The experimental group (4 men, 4 women) received electromyographic biofeedback treatment together with physical therapy. The control group (5 men, 3 women) was treated with physical therapy only. Clinical and functional evaluations before and after treatment were performed using Canadian Neurological, Adams, Ashworth, Basmajian, and Barthel Index scales. Computerized gait analysis was performed in all patients. RESULTS: Electromyographic biofeedback patients showed significantly increased scores on the Adams scale (P < .05) and Basmajian scale (P < .01). Gait analysis in this group showed a recovery of foot-drop in the swing phase (P < .02) after training. CONCLUSIONS: Our data confirm that the electromyographic biofeedback technique increases muscle strength and improves recovery of functional locomotion in patients with hemiparesis and foot-drop after cerebral ischemia.

Adult↗
PubMed1994

Laboratory tests in rheumatology.

The most commonly used laboratory tests in the diagnosis and monitoring of rheumatic diseases are reviewed. Particular emphasis is placed on antinuclear antibodies as markers of specific rheumatic disorders and disease subsets. The use of synovial fluid tests to differentiate between inflammatory and noninflammatory rheumatic disorders is described as well as the use of common hematological tests.

Antibodies, Antinuclear↗
PubMed1993

Treatment of postmenopausal osteoporosis with continuous daily oral alendronate in comparison with either placebo or intranasal salmon calcitonin.

Alendronate sodium (ALN) is a potent amino bisphosphonate which specifically inhibits osteoclastic bone resorption and has been found to reverse bone loss in several animal models. To determine if daily oral ALN treatment could prevent or reverse bone loss in osteoporotic postmenopausal women, and to compare ALN to intranasal salmon calcitonin (CT), a 2-year, double-masked, randomized, placebo-controlled study was initiated at 9 clinical centers in Italy. Two hundred and eighty six postmenopausal women (age 48-76) with spinal bone mineral density (BMD) > or = 2 SD below adult mean peak, with or without vertebral crush fractures, were randomized to one of four treatment arms: ALN 10 mg daily, ALN 20 mg daily or matching placebo (these groups all double-masked), or CT 100 IU daily (open label) for 2 years. All patients received supplemental calcium (as carbonate) 500 mg daily. Bone mass was measured by dual-energy X-ray absorptiometry of the PA lumbar spine (LS) and proximal femur (femoral neck and trochanter) at 6-month intervals. Subject safety was measured through sequential clinical and laboratory evaluation. A planned 1-year interim analysis of this ongoing study was performed centrally in a manner that maintains the double-mask for all subjects receiving oral study drug. Relative to PBO, ALN at either 10 mg or 20 mg daily increased LS BMD by 4.7% and 6.1%, respectively; each increased femoral neck BMD by 3.1% and increased trochanter BMD by 3.3% and 3.8% respectively. In contrast, CT failed to significantly increase BMD of either the spine, femoral neck or trochanter, either relative to baseline or to PBO.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intranasal↗