Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Overview

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.

Full Title of Study: “Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 1, 2023

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Denosumab and Raloxifene
    • denosumab and raloxifene
  • Active Comparator: Denosumab and Alendronate
    • denosumab and alendronate

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Postmenopausal women

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Joy Tsai, Assistant Professor, Harvard Medical School – Massachusetts General Hospital
  • Overall Official(s)
    • Joy Tsai, MD, Principal Investigator, MGH

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