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Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04026256
Collaborator
(none)
37
Enrollment
1
Location
3
Arms
31.5
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Actual Study Start Date :
Sep 2, 2019
Actual Primary Completion Date :
Apr 18, 2022
Actual Study Completion Date :
Apr 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Teriparatide only

daily subcutaneous injection teriparatide for 3 months

Drug: Teriparatide
teriparatide daily subcutaneous injection
Other Names:
  • Forteo

    		•
    Active Comparator: Denosumab only

    one dose of subcutaneous injection denosumab

    Drug: Denosumab
    denosumab subcutaneous injection
    Other Names:
  • Prolia

    		•
    Active Comparator: Denosumab and teriparatide

    daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab

    Drug: Teriparatide
    teriparatide daily subcutaneous injection
    Other Names:
  • Forteo

    • Drug: Denosumab
    denosumab subcutaneous injection
    Other Names:
  • Prolia

    		•

    Outcome Measures

    Primary Outcome Measures

    1. cancellous bone formation rate/bone surface (BFR/BS) (mm3/mm2/y) [3 months after first dose of study drug]

    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

    Exclusion Criteria:

    • significant previous use of bone health modifying treatments

    • 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/mL or >60ng/mL

    • serum alkaline phosphatase above upper normal limit with no explanation

    • anemia (hematocrit <32%)

    • history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or gouty arthritis

    • history of urolithiasis within the last one year

    • excessive alcohol use or substance abuse

    • use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months

    • extensive dental work involving extraction or dental implant within the past or upcoming 2 months

    • known sensitivity to mammalian cell-derived drug products

    • known contraindications to denosumab, teriparatide, or any of their excipients

    • known contraindications to tetracycline, demeclocycline, or other antibiotics in this drug class

    • continuous use of tetracycline for >1-month duration within the last 10 years

    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: Benjamin Leder, MD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04026256
    Other Study ID Numbers:
    • 2018P002537
    First Posted:
    Jul 19, 2019
    Last Update Posted:
    Jul 29, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital
    osteoporosis
    histomorphometry
    bone density
    teriparatide
    denosumab
    Additional relevant MeSH terms:
    Osteoporosis
    Osteoporosis, Postmenopausal
    Denosumab
    Teriparatide

    Study Results

    No Results Posted as of Jul 29, 2022