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Comparative Antiresorptive Efficacy Discontinuation of Denosumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03623633
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : September 11, 2020
Information provided by (Responsible Party):
Joy Tsai, Massachusetts General Hospital

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
Osteoporosis, Postmenopausal Osteoporosis Drug: denosumab Drug: alendronate Drug: raloxifene Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 71 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 : November 30, 2018
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Arm Intervention/treatment
Active Comparator: Denosumab and Raloxifene
denosumab and raloxifene
Drug: denosumab
denosumab 60 milligrams subcutaneously every 6 months
Other Name: Prolia

Drug: raloxifene
raloxifene 60 milligrams daily
Other Name: Evista

Active Comparator: Denosumab and Alendronate
denosumab and alendronate
Drug: denosumab
denosumab 60 milligrams subcutaneously every 6 months
Other Name: Prolia

Drug: alendronate
alendronate 70 milligrams weekly
Other Name: Fosamax

Primary Outcome Measures :
  1. Serum c-telopeptide (CTX) [ Time Frame: 18 months ]
    Change in serum CTX between month 12 and month 18

  2. Bone mineral density (BMD) [ Time Frame: 36 months ]
    Change in PA spine BMD between month 24 and month 36

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal women
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03623633

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Contact: Grace Sassana, BA 6177242035

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Grace Sassana    617-724-2035   
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Joy Tsai, MD MGH
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Responsible Party: Joy Tsai, Instructor, Harvard Medical School, Massachusetts General Hospital Identifier: NCT03623633    
Other Study ID Numbers: 2018P001612
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Raloxifene Hydrochloride
Bone Density Conservation Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators