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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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,431 Previous Clinical Trials
2,460,806 Total Patients Enrolled
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,661 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions does alendronate typically treat?

"Alendronate has been demonstrated to help ameliorate symptoms of tumors, solid masses, osteoporosis and malignant neoplasms."

Answered by AI

Has alendronate received the endorsement of the FDA?

"Our Power analysts assigned alendronate a rating of 2 on their safety scale, as the drug has been through initial trials and there is some evidence that it can be used safely but no data to support its efficacy."

Answered by AI

What is the scope of individuals involved in this clinical experiment?

"Affirmative. Per the information posted on clinicaltrials.gov, this experiment is in need of participants and had been modified as recently as January 25th 2021. The trial requires 34 individuals to be recruited from two separate sites."

Answered by AI

Are there any eligibility criteria which would preclude me from participating in this research?

"This clinical trial seeks to recruit 34 individuals with osteoporosis, aged between 20 and 55. The essential requisites for enrollment are that participants have had 12 months of Forteo treatment and at least 1 year of denosumab as part of a past study. Additionally, they must not present any medical issue or history related medication exposure listed in the protocol."

Answered by AI

Are there any other research endeavors that have utilized alendronate?

"Alendronate first made its clinical debut at Rosemere Cancer Centre, Royal Preston Hospital in 2005. Nowadays, there are 46 active trials and a total of 240 completed investigations. Notably, many of these studies are hosted out of Omaha, Nebraska."

Answered by AI

Do you accept participants aged under 60 years for this trial?

"The age range for this trial is delineated by the eligibility criteria, which states that participants have to be between 20 and 55 years old."

Answered by AI

Are any further participants being recruited into this clinical experiment?

"Affirmative. According to the data posted on clinicaltrials.gov, this medical study is actively enrolling patients; it was initially released on January 29th 2018 and recently updated in late 2021. The trial needs 34 participants from two different locations for full completion."

Answered by AI
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~4 spots leftby Apr 2025