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Purpose

In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.

Conditions

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • women aged 45+ - postmenopausal - osteoporotic with high risk of fracture

Exclusion Criteria

  • no 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/dL - anemia (hematocrit <32%) - history of malignancy (except non-melanoma skin carcinoma) - excessive alcohol use or substance abuse - known contraindications to romosozumab or teriparatide

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Romosozumab 		romosozumab
  • Drug: Romosozumab
    romosozumab 210 milligrams monthly
    Other names:
    • Evenity
  • Drug: Teriparatide
    teriparatide 20 micrograms daily
    Other names:
    • Forteo
Active Comparator
Romosozumab and Teriparatide 		romosozumab and teriparatide
  • Drug: Romosozumab
    romosozumab 210 milligrams monthly
    Other names:
    • Evenity
  • Drug: Teriparatide
    teriparatide 20 micrograms daily
    Other names:
    • Forteo

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Aparna Patnaik, BA
617-726-6129
apatnaik1@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Aparna Patnaik, BA
617-726-6129
apatnaik1@mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.