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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03623633
Other study ID # 2018P001612
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date November 30, 2018
Est. completion date August 1, 2023

Study information

Verified date June 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 51
Est. completion date August 1, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
denosumab
denosumab 60 milligrams subcutaneously every 6 months
alendronate
alendronate 70 milligrams weekly
raloxifene
raloxifene 60 milligrams daily

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum c-telopeptide (CTX) Change in serum CTX between month 12 and month 18 Month 12 to 18 months
Primary Bone mineral density (BMD) Change in PA spine BMD between month 24 and month 36 Month 24 to 36 months
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