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Trial record 1 of 1 for:    NCT04026256
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Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

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ClinicalTrials.gov Identifier: NCT04026256
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Leder, MD, Massachusetts General Hospital

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
Postmenopausal Osteoporosis Drug: Teriparatide Drug: Denosumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Actual Study Start Date : October 4, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Teriparatide only
daily subcutaneous injection teriparatide for 3 months
Drug: Teriparatide
teriparatide daily subcutaneous injection
Other Name: Forteo

Active Comparator: Denosumab only
one dose of subcutaneous injection denosumab
Drug: Denosumab
denosumab subcutaneous injection
Other Name: 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 Name: Forteo

Drug: Denosumab
denosumab subcutaneous injection
Other Name: Prolia




Primary Outcome Measures :
  1. Change From Baseline to 3 Months in Cancellous Bone Formation Rate [ Time Frame: 3 months after first dose of study drug ]


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
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT04026256


Contacts
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Contact: Sabashini Ramchand, MD 617-643-6891 sramchand@mgh.harvard.edu
Contact: Natalie David, BS 617-726-6129

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Sabashini Ramchand    617-643-6891    sramchand@mgh.harvard.edu   
Contact: Natalie David    617-726-6129    ndavid2@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Benjamin Leder, MD Massachusetts General Hospital
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Responsible Party: Benjamin Leder, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04026256    
Other Study ID Numbers: 2018P002537
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Leder, MD, Massachusetts General Hospital:
osteoporosis
histomorphometry
bone density
teriparatide
denosumab
Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Denosumab
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents