Suspended

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

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What is being tested

Apomine

Drug
Who is being recruted

Osteoporosis

From 45 to 75 Years
+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2003

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Summary

Principal SponsorGenzyme, a Sanofi Company
Last updated: February 5, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2003Actual date on which the first participant was enrolled.

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. 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.

Official TitleA Phase I/II Randomized Study of the Short-Term Effects of APOMINE vs Placebo in Postmenopausal Women With Osteoporosis or Low Bone Mass 
Principal SponsorGenzyme, a Sanofi Company
Last updated: February 5, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
60 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 45 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Osteoporosis
Criteria
10 inclusion criteria required to participate
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)

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11 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Unknown FacilityOmaha, United StatesSee the location
Suspended
Unknown FacilityWest Haverstraw, United States
Suspended2 Study Centers