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Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis Clinical research trials and Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis. Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis clinical trial. Human subjects often receive the most effective healthcare possible for their Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis  Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis
Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis
For Condition: Osteoporosis
Status: Not yet recruiting
Sponsor(s): Hoffmann-La Roche ,
Synopsis: The purposes of this study are to study the effect of long-term treatment with monthly oral ibandronate 100 mg and 150 mg, given as a single tablet, on the lumbar spine and hip bone mineral density (BMD) and bone turnover, and to assess the overall long-term tolerability and safety of the treatment regimens.
Details:
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 57 Years/82 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: - Patients who completed study BM16549 (2-year treatment oral ibandronate, 2.5 mg, 100 mg or 150 mg, double-blind) and who had complied with the monthly regimen for 75% or more - Patients who are ambulatory at the beginning of the trial. It must not be anticipated that the patient becomes hospitalized, immobilized, or bedridden during the course of the trial - Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration - Patients who have provided written informed consent to participate in the study Exclusion Criteria: - Severe renal failure (1 calculated GFR less than 30 ml/min.) - Malignant disease diagnosed within the previous 12 years (except successfully resected basal cell cancer) - Breast cancer diagnosed within the previous 22 years - Disease/disorder known to influence bone metabolism: Chronic gastrointestinal or liver disease, chronic alcoholism, severe malabsorption syndrome, primary hyperparathyroidism (patients with surgically treated hyperparathyroidism with documented normal serum calcium and PTH will be eligible for enrollment), Paget's disease of bone, histologically documented osteomalacia, or documented active thyroid disease without treatment - Administration of any investigational drug other than ibandronate within 30 days preceding the first dose of the study drug - Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 months, or for more than 2 years (total duration) - Treatment with PTH or similar agent for osteoporosis within the last 2 years - Treatment with any bisphosphonate other than oral ibandronate since inclusion in BM16549 - Treatment with other drugs affecting bone metabolism within the last 6 months · Chronic systemic corticosteroid treatment · Systemic hormones (e.g. estrogens, progestins, SERMs, anabolic steroids, active Vit. D analogs/metabolites, calcitonin) · Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: MA17903;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00081653
Other Osteoporosis Studies:
1. An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass
2. Phase 2 Study assessing AMG 162 in the treatment of women with low bone density
3. Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
4. Bone Estrogen Strength Training
5. Efficacy and safety study of intravenous ibandronate to treat postmenopausal osteoporosis as compared to daily oral ibandronate
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Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis
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