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Comparative Antiresorptive Efficacy Discontinuation of Denosumab

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03623633
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
56
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparative Antiresorptive Efficacy of Alendronate or Raloxifene Following Discontinuation of Denosumab
Actual Study Start Date :
Nov 30, 2018
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum c-telopeptide (CTX) [Month 12 to 18 months]

      Change in serum CTX between month 12 and month 18

    2. Bone mineral density (BMD) [Month 24 to 36 months]

      Change in PA spine BMD between month 24 and month 36

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital

    Investigators

    • Principal Investigator: Joy Tsai, MD, MGH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joy Tsai, Assistant Professor, Harvard Medical School, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03623633
    Other Study ID Numbers:
    • 2018P001612
    First Posted:
    Aug 9, 2018
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Denosumab
    Alendronate
    Raloxifene Hydrochloride

    Study Results

    No Results Posted as of Jun 8, 2022