Combined Anabolic Therapy

Phase 4RecruitingNCT06558188

Massachusetts General Hospital50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Osteoporosis, Postmenopausal Osteoporosis

Interventions

RomosozumabDRUG

romosozumab 210 milligrams monthly

TeriparatideDRUG

teriparatide 20 micrograms daily

Eligibility

Sex: FEMALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Lumbar spine areal bone mineral density

Change in lumbar spine bone density between month 0 and month 12

Time frame: Month 0 to 12

Central Contacts

Aparna Patnaik, BA

CONTACT

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

Data from ClinicalTrials.gov

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