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Active, not recruiting Phase 4 Interventional Accepts healthy volunteers

Comparative Antiresorptive Efficacy Discontinuation of Denosumab

ClinicalTrials.gov ID: NCT03623633

Public ClinicalTrials.gov record NCT03623633. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 22, 2026, 2:49 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT03623633
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 4
Enrollment
51 participants

Conditions and interventions

Eligibility (public fields only)

Age range
45 Years and older
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 29, 2018
Primary completion
Jan 31, 2023
Completion
Jul 31, 2023
Last update posted
Jun 6, 2023

2018 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Massachusetts General Hospital Boston Massachusetts 02114

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03623633, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 6, 2023 · Synced Sep 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03623633 live on ClinicalTrials.gov.

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