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Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women with Postmenopausal Osteoporosis conditions. Clinical Trials Search.org is a site devoted 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 many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, 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 have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally 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. Test subjects oftentimes 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. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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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. Women's Health Initiative (WHI)
2. Bone Development in Adolescent Girls: Effects of Calcium and Exercise
3. Macrobiotic Diet and Flax Seed: Effects on Estrogens, Phytoestrogens, & Fibrinolytic Factors
4. Effects of Parathyroid Hormone in Men with Osteoporosis
5. Treatment of Childhood Osteoporosis with Alendronate (Fosamax)
Related Studies:
Other Osteoporosis Clinical Trials
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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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