Combined Anabolic Therapy (CAT)

Combined Anabolic Therapy Study

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 Overview

• Status: Recruiting
• Conditions: Osteoporosis; Osteoporosis, Postmenopausal
• Intervention / Treatment: Drug: Romosozumab; Drug: Teriparatide

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Aparna Patnaik, BA; Phone Number: 617-726-6129; Email: apatnaik1@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Aparna Patnaik, BA; Phone Number: 617-726-6129; Email: apatnaik1@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Romosozumab; romosozumab	Drug: Romosozumab; romosozumab 210 milligrams monthly; Other Names: Evenity
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lumbar spine areal bone mineral density	Change in lumbar spine bone density between month 0 and month 12	Month 0 to 12

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Benjamin Leder, MD, MGH

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis; Osteoporosis, Postmenopausal; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Parathyroid Hormone; Teriparatide; romosozumab
• Other Study ID Numbers: 2024P002279; 1R21AR083567-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes