Recruiting
Phase 4

Osteoporosis Treatment

Sponsor:

Massachusetts General Hospital

Code:

NCT06558188

Conditions

Osteoporosis, Postmenopausal

Osteoporosis

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Accepted

Interventions

Romosozumab

Teriparatide

Study Details

Brief 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.

Conditions

Osteoporosis, Postmenopausal

Osteoporosis

Study ID

NCT06558188

Start date

Feb 3, 2025

Status verified date

Oct, 2026

Completion date

Nov 19, 2027

Anticipated

Primary completion date

Nov 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 45+

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Romosozumab

romosozumab

active comparator: Romosozumab and Teriparatide

romosozumab and teriparatide

Interventions

Romosozumab

romosozumab 210 milligrams monthly

Teriparatide

teriparatide 20 micrograms daily

Primary outcome measure

  • Lumbar spine areal bone mineral density [ Time Frame: Month 0 to 12 ]

Central Contacts and Locations

Central contacts

Aparna Patnaik, BA

617-726-6129apatnaik1@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Aparna Patnaik, BA

617-726-6129apatnaik1@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.