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Osteoporosis Agent

Denosumab alone for Osteoporosis

Phase 4

Waitlist Available

Research Sponsored by Felicia Cosman, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 12, 18 months

Awards & highlights

Study Summary

This trial will compare the effects of two different treatments on postmenopausal women's bone mineral density over 18 months. The primary outcome will be group differences in bone mineral density of the total hip and lumbar spine at 18 months.

Eligible Conditions

Osteoporosis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 12, 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6, 12, 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 12, 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bone mineral density changes at total hip and lumbar spine

Secondary outcome measures

Bone mineral density changes in increments

Differences in biochemical bone turnover markers

Trabecular Bone Score changes

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Denosumab aloneActive Control1 Intervention

3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.

Group II: Combination therapyActive Control2 Interventions

3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Felicia Cosman, MDLead Sponsor

Crozer-Keystone Health SystemOTHER

4 Previous Clinical Trials

224 Total Patients Enrolled

Radius Health, Inc.Industry Sponsor

14 Previous Clinical Trials

21,103 Total Patients Enrolled

11 Trials studying Osteoporosis

20,952 Patients Enrolled for Osteoporosis

Frequently Asked Questions

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

To what health conditions is combination therapy typically prescribed?

"Skeletally mature individuals exhibiting bone and/or androgen-related issues can be aided by a Combination therapy approach."

Answered by AI

Is there an ongoing recruitment of participants for this trial?

"According to clinicaltrials.gov, this research trial is still actively searching for participants; initial postings were made on February 1st 2021 and the study has been updated as recently as December 2nd of that same year."

Answered by AI

What adverse consequences could manifest from Combination therapy for patients?

"Our experts assigned a rank of 3 to combination therapy, which has been approved and is currently in the fourth phase."

Answered by AI

What prior experiments have been conducted to assess the efficacy of combination treatments?

"Currently, 12 clinical trials for Combination therapy have reached Phase 3 and 53 are still ongoing. There are numerous locations offering this medication with 482 sites scattered throughout the United States of America; notably several in Boston, Massachusetts."

Answered by AI

What is the aggregate patient population participating in this experiment?

"Indeed, public records on clinicaltrials.gov indicate that this trial is actively recruiting patients. Initially posted in February 2021 and most recently updated in December of the same year, 70 individuals must be sourced from one medical centre to complete the study."

Answered by AI

Recent research and studies

Journal of Bone and Mineral ResearchJournal

Hip and Spine Strength Effects of Adding Versus Switching to Teriparatide in Postmenopausal Women with Osteoporosis Treated with Prior Alendronate or Raloxifene

Cosman, Felicia, Tony M Keaveny, David Kopperdahl, Robert A Wermers, Xiaohai Wan, Kelly D Krohn, and John H Krege. 2013. “Hip and Spine Strength Effects of Adding Versus Switching to Teriparatide in Postmenopausal Women with Osteoporosis Treated with Prior Alendronate or Raloxifene”. Journal of Bone and Mineral Research. Wiley. doi:10.1002/jbmr.1853.

The Journal of Clinical Endocrinology & MetabolismJournal

Two Years of Denosumab and Teriparatide Administration in Postmenopausal Women with Osteoporosis (the DATA Extension Study): A Randomized Controlled Trial

Leder, Benjamin Z., Joy N. Tsai, Alexander V. Uihlein, Sherri-Ann M. Burnett-Bowie, Yuli Zhu, Katelyn Foley, Hang Lee, and Robert M. Neer. 2014. “Two Years of Denosumab and Teriparatide Administration in Postmenopausal Women with Osteoporosis (the DATA Extension Study): A Randomized Controlled Trial”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2013-4440.

The Journal of Clinical Endocrinology & MetabolismJournal

Effects of Teriparatide in Postmenopausal Women with Osteoporosis on Prior Alendronate or Raloxifene: Differences Between Stopping and Continuing the Antiresorptive Agent

Cosman, Felicia, Robert A. Wermers, Christopher Recknor, Karen F. Mauck, Li Xie, Emmett V. Glass, and John H. Krege. 2009. “Effects of Teriparatide in Postmenopausal Women with Osteoporosis on Prior Alendronate or Raloxifene: Differences Between Stopping and Continuing the Antiresorptive Agent”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2008-2719.

The LancetJournal