Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2025-02-03
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Romosozumab
romosozumab
Romosozumab
romosozumab 210 milligrams monthly
Romosozumab and Teriparatide
romosozumab and teriparatide
Romosozumab
romosozumab 210 milligrams monthly
Teriparatide
teriparatide 20 micrograms daily
Interventions
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Romosozumab
romosozumab 210 milligrams monthly
Teriparatide
teriparatide 20 micrograms daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* postmenopausal
* osteoporotic with high risk of fracture
Exclusion Criteria
* 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
* known contraindications to romosozumab or teriparatide
45 Years
FEMALE
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Benjamin Leder, MD
Professor of Medicine
Principal Investigators
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Benjamin Leder, MD
Role: PRINCIPAL_INVESTIGATOR
MGH
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024P002279
Identifier Type: -
Identifier Source: org_study_id
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