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Bisphosphonates for Osteoporosis Prevention After Denosumab

Phase 2
Waitlist Available
Led By Elizabeth Shane, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 month
Awards & highlights

Study Summary

This trial is being done to see if taking bisphosphonates after stopping denosumab will help prevent bone loss in premenopausal women with idiopathic osteoporosis.

Who is the study for?
This trial is for premenopausal women who have completed at least 12 months of Forteo and denosumab treatments for idiopathic osteoporosis. Participants should not have inflammatory bowel disease, malabsorption, calcium supplement intolerance, or conditions that could affect the study's results. They must be able to consent voluntarily and not have renal insufficiency, liver disease, abnormal calcium levels, vitamin D deficiency, contraindications to bisphosphonate treatment like hypersensitivity or a history of certain bone diseases.Check my eligibility
What is being tested?
The study tests whether bisphosphonates (Zoledronic Acid or Alendronate) can prevent bone mass loss in women after they stop taking denosumab. It will monitor the effects during one year on therapy followed by another year off therapy to see how long the benefits last.See study design
What are the potential side effects?
Possible side effects from Zoledronic Acid and Alendronate include flu-like symptoms such as fever and chills; pain in bones, joints, or muscles; nausea; heartburn; irritation of the esophagus; low blood calcium levels; and rarely jawbone problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in BMD at the Lumbar Spine (L1-4) Within Group

Trial Design

2Treatment groups
Active Control
Group I: alendronateActive Control1 Intervention
Subjects will receive oral alendronate
Group II: zoledronic acidActive Control1 Intervention
Subjects will receive zoledronic acid

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Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,439 Previous Clinical Trials
2,448,795 Total Patients Enrolled
AmgenIndustry Sponsor
1,383 Previous Clinical Trials
1,379,823 Total Patients Enrolled
Elizabeth Shane, MD5.0215 ReviewsPrincipal Investigator - Columbia University
Medical School - Howard University, Doctor of Medicine
Columbia University, Saint Luke's-Roosevelt Hospital Center, Residency in Dermatology
6 Previous Clinical Trials
360 Total Patients Enrolled
5Patient Review
Dr. Perry is extremely knowledgeable and takes a very thorough approach.

Media Library

alendronate Clinical Trial Eligibility Overview. Trial Name: NCT03396315 — Phase 2
alendronate 2023 Treatment Timeline for Medical Study. Trial Name: NCT03396315 — Phase 2
~3 spots leftby Jun 2025
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