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

NCT00078026 | Terminated Phase 1

• 1 other identifier: APB-231
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Osteoporosis

Keywords

Apomine; Osteoporosis; Bone Mass; Postmenopausal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Interventions

Apomine DRUG

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (2)

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

West Haverstraw, New York, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

apomine

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 16, 2004
• First Posted: February 19, 2004
• Study Start: August 1, 2003
• Study Completion: December 1, 2004
• Last Updated: February 5, 2014

Record last verified: 2014-02

Locations

US (2)