Comparative Antiresorptive Efficacy Discontinuation of Denosumab

  • STATUS
    Recruiting
  • End date
    Jan 1, 2025
  • participants needed
    71
  • sponsor
    Massachusetts General Hospital
Updated on 2 May 2021
denosumab
osteoporosis
bisphosphonate
RANKL
alendronate
teriparatide
raloxifene
postmenopausal osteoporosis
abaloparatide

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.

Details
Condition Osteopenia, Osteoporosis, Postmenopausal osteoporosis, Post-Menopausal Osteoporosis, Post-Menopausal Osteopenia
Treatment Alendronate, raloxifene, Denosumab
Clinical Study IdentifierNCT03623633
SponsorMassachusetts General Hospital
Last Modified on2 May 2021

Eligibility

Yes No Not Sure

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
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