Combined Anabolic Therapy (CAT)

Mass General Brigham

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Osteoporosis; Osteoporosis, Postmenopausal

Treatments: Drug: Romosozumab; Drug: Teriparatide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06558188

2024P002279

1R21AR083567-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Romosozumab

Active Comparator group

Description:

romosozumab

Treatment:

Drug: Romosozumab

Romosozumab and Teriparatide

Active Comparator group

Description:

romosozumab and teriparatide

Treatment:

Drug: Teriparatide

Drug: Romosozumab