Status:
TERMINATED
An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Osteoporosis
Eligibility:
FEMALE
45-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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 oophorectomy) 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
- 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.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00078026
Start Date
August 1 2003
End Date
December 1 2004
Last Update
February 5 2014
Active Locations (2)
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1
Omaha, Nebraska, United States
2
West Haverstraw, New York, United States