Comparative Antiresorptive Efficacy Discontinuation of Denosumab

June 5, 2023 updated by: Joy Tsai, Massachusetts General Hospital

Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab

Osteoporosis remains a significant healthcare burden for the United States. Current FDA-approved osteoporosis treatments include teriparatide, abaloparatide, bisphosphonates, denosumab, and raloxifene.

Denosumab is a fully human monoclonal antibody that specifically binds to receptor activator of nuclear factor kappa-B ligand (RANKL). Denosumab potently suppresses osteoclastic activity but bone turnover rapidly normalizes and bone turnover marker levels can rebound above baseline levels after the drug is discontinued.

This study will help us determine the optimal duration and relative efficacy of two oral antiresorptive medications that are FDA-approved for treatment of postmenopausal osteoporosis (alendronate and raloxifene) in preventing the rebound increase in bone turnover that occurs after denosumab discontinuation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • women aged 45+
  • postmenopausal
  • osteoporotic with high risk of fracture as per National Osteoporosis Foundation guidelines

Exclusion Criteria:

  • no significant previous use of bone health modifying treatments
  • hip fracture within one year of enrollment
  • known congenital or acquired bone disease other than osteoporosis
  • significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
  • abnormal calcium or parathyroid hormone level
  • serum vitamin D <20 ng/dL
  • anemia (hematocrit <32%)
  • history of malignancy (except non-melanoma skin carcinoma)
  • excessive alcohol use or substance abuse
  • extensive dental work involving extraction or dental implant within the past 6 months or in the upcoming 12 months
  • known contraindications to denosumab, alendronate, or raloxifene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Denosumab and Raloxifene
denosumab and raloxifene
Drug: denosumab
denosumab 60 milligrams subcutaneously every 6 months
Other Names:
  • Prolia
Drug: raloxifene
raloxifene 60 milligrams daily
Other Names:
  • Evista
Active Comparator: Denosumab and Alendronate
denosumab and alendronate
Drug: denosumab
denosumab 60 milligrams subcutaneously every 6 months
Other Names:
  • Prolia
Drug: alendronate
alendronate 70 milligrams weekly
Other Names:
  • Fosamax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum c-telopeptide (CTX)
Time Frame: Month 12 to 18 months
Change in serum CTX between month 12 and month 18
Month 12 to 18 months
Bone mineral density (BMD)
Time Frame: Month 24 to 36 months
Change in PA spine BMD between month 24 and month 36
Month 24 to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Joy Tsai, MD, MGH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2018

Primary Completion (Actual)

February 1, 2023

Study Completion (Estimated)

August 1, 2023

Study Registration Dates

First Submitted

August 6, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018P001612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoporosis

Clinical Trials on denosumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe