Combined Anabolic Therapy

NCT ID: NCT06558188

Last Updated: 2025-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-03

Study Completion Date

2027-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis, Postmenopausal Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Romosozumab

romosozumab

Group Type ACTIVE_COMPARATOR

Romosozumab

Intervention Type DRUG

romosozumab 210 milligrams monthly

Romosozumab and Teriparatide

romosozumab and teriparatide

Group Type ACTIVE_COMPARATOR

Romosozumab

Intervention Type DRUG

romosozumab 210 milligrams monthly

Teriparatide

Intervention Type DRUG

teriparatide 20 micrograms daily

Interventions

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Romosozumab

romosozumab 210 milligrams monthly

Intervention Type DRUG

Teriparatide

teriparatide 20 micrograms daily

Intervention Type DRUG

Other Intervention Names

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Evenity Forteo

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Leder, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Leder, MD

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aparna Patnaik, BA

Role: CONTACT

617-726-6129

Facility Contacts

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Aparna Patnaik, BA

Role: primary

617-726-6129

Other Identifiers

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1R21AR083567-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024P002279

Identifier Type: -

Identifier Source: org_study_id

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