Combined Anabolic Therapy

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

  • Osteoporosis, Postmenopausal
  • Osteoporosis

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