Combined Anabolic Therapy

Last updated: March 13, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Osteoporosis

Treatment

Romosozumab

Teriparatide

Clinical Study ID

NCT06558188
2024P002279
1R21AR083567-01A1
  • Ages > 45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • women aged 45+

  • postmenopausal

  • osteoporotic with high risk of fracture

Exclusion

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 psychiatricdisease

  • 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

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Romosozumab
Phase: 4
Study Start date:
February 03, 2025
Estimated Completion Date:
July 01, 2027

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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