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An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass Clinical research trials and An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass. An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass clinical trial. Test subjects typically receive the most expert healthcare available for their An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass  An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass
An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass
For Condition: Osteoporosis
Status: Recruiting
Sponsor(s): ILEX Products ,
Synopsis: Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.
Details: This study is a randomized, placebo-controlled, double-blind, parallel-group study to investigate the efficacy and safety of administering 3 dose levels of APOMINE at 25, 50, or 100 mg/day or placebo once a day as a capsule to postmenopausal women with low bone mass or osteoporosis. Eligible patients must be women between 45 and 75 years of age, have a diagnosed low bone mineral density or osteoporosis, and be at least 3 years post menopause. The primary endpoint of the study will be changes in bone formation markers (bone alkaline phosphatase and osteocalcin). The secondary endpoint of the study will be changes in bone formation markers (bone alkaline phosphatase, osteocalcin, and P-ICP) and bone resorption markers (serum C-telopeptide, urinary N-telopeptide). Blood samples will be drawn at each study visit to determine these bone markers as well as for normal laboratory tests. Bone mineral density measurements (DEXA) will be performed at the beginning and at the end of the study. Up to 60 subjects will be randomized as a cohort for treatment and treated with 25, 50, or 100 mg/day or placebo (15 subjects per group). All enrolled subjects will receive a daily calcium and Vitamin D supplement.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 45 Years/75 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria: All patients must meet all of the following criteria for study entry: - A diagnosis of osteoporosis or low bone mass (T score < or = to -1). - Female, 45 to 75 years old (inclusive). - Postmenopausal (cessation of menses or oophorectemy) by at least 3 years. - Bone mineral density: (BMD) at spine or hip >1 standard deviation below mean for young normals of same sex (T score < or = to -1). - Adequate liver function as indicated by a total bilirubin, AST, and ALT being within institutional normal limits. - Serum creatinine within institutional normal limits. - Signed, written informed consent. - Able to comply with study procedures and follow-up examinations. - Ionized calcium and 25-hydroxyvitamin D3 must be within institutional normal limits. - PTH must be within institutional normal limits. Exclusion Criteria: Patients who meet any of the following criteria will be excluded from study entry: - Known hypersensitivity to study drug or related compounds (e.g., bisphosphonates). - Use of any drugs for treatment of osteoporosis in the previous 6 months (e.g., bisphosphonates, hormone-replacement therapy [HRT]). - Any chronic or continued use of drugs that are known to affect bone metabolism (e.g., diuretics, glucocorticoids, oral contraceptives). - Gallstone diagnosed within the past 5 years or a history of multiple gallstones. - Previous significant gastrointestinal surgery (except appendectomy) or gastrointestinal disease. - Abnormal thyroid function (by thyroid-stimulating hormone [TSH] assay, normal range 0.5-5.0 U/L). - Secondary osteoporosis (e.g., steroid-induced) and/or any other disorder affecting calcium or mineral metabolism. - Use of investigational agents within previous 30 days. - Patients with existing heart problems (e.g., congestive heart failure, unstable angina, conduction delay). - Patients taking calcium channel blockers, beta blockers, digitalis, or antihypertensive agents. - Any other concurrent disease or condition that, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Total Enrollment: 60
Location and Contact Information:
Additional Information:
Study ID Numbers: APB-231;
Study Start Date: January 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078026
Other Osteoporosis Studies:
1. CVD Risk and Health in Postmenopausal Phytoestrogen Users
2. Osteoporosis Prevention After Heart Transplant
3. Comparison of Study Drug With Alendronate on How it Effects Glucocorticoid-Induced Osteoporosis
4. Calcium With or Without Estrogen and/or Risedronate in Preventing Osteoporosis in Patients with Prostate Cancer
5. Building Better Bones in Children
Related Studies:
Other Osteoporosis Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
An investigation into the short term effect of APOMINE in patients with Osteoporosis or Low Bone Mass
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