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An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass

This study has been terminated.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00078026
First received: February 16, 2004
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Apomine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase I/II Randomized Study of the Short-Term Effects of APOMINE vs Placebo in Postmenopausal Women With Osteoporosis or Low Bone Mass

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Osteoporosis/low bone mass subjects treated with 3 levels (25, 50 or 100 mg/day) of Apomine or placebo. Efficacy measured by changes in baseline in: biochemical indicators of bone formation and bone resorption and BMD.

Secondary Outcome Measures:
  • To evaluate the quantitative and qualitative toxicities, as well as limited pharmacokinetics in this population.

Estimated Enrollment: 60
Study Start Date: August 2003
Estimated Study Completion Date: December 2004
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 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

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078026

Locations
United States, Nebraska
Omaha, Nebraska, United States
United States, New York
West Haverstraw, New York, United States
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00078026     History of Changes
Other Study ID Numbers: APB-231
Study First Received: February 16, 2004
Last Updated: February 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Apomine
Osteoporosis
Bone Mass
Postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014