NCT06558188

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
23mo left

Started Feb 2025

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Feb 2025Apr 2028

First Submitted

Initial submission to the registry

August 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

August 14, 2024

Last Update Submit

April 14, 2026

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Outcome Measures

Primary Outcomes (1)

  • Lumbar spine areal bone mineral density

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

    Month 0 to 12

Study Arms (2)

Romosozumab

ACTIVE COMPARATOR

romosozumab

Drug: Romosozumab

Romosozumab and Teriparatide

ACTIVE COMPARATOR

romosozumab and teriparatide

Drug: RomosozumabDrug: Teriparatide

Interventions

RomosozumabDRUG

romosozumab 210 milligrams monthly

Also known as: Evenity
RomosozumabRomosozumab and Teriparatide
TeriparatideDRUG

teriparatide 20 micrograms daily

Also known as: Forteo
Romosozumab and Teriparatide

Eligibility Criteria

Age45 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women aged 45+
  • postmenopausal
  • osteoporotic with high risk of fracture

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Osteoporosis, PostmenopausalOsteoporosis

Interventions

romosozumabTeriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid HormonePeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Benjamin Leder, MD

    MGH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aparna Patnaik, BA

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

February 3, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

US(1)