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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Active, not recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.