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Trial · Interventional

RecruitingPhase 4Registry data

Combined Anabolic Therapy

Short name CAT

NCTNCT06558188 (opens ClinicalTrials.gov in a new tab)Other id2024P002279Other id1R21AR083567-01A1
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
50 participants (estimated)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
3 Feb 2025
Primary completion
2 Nov 2027 (estimated)
Completion
19 Nov 2027 (estimated)
First posted
16 Aug 2024
Last update posted
8 Oct 2026
Conditions
Osteoporosis, Postmenopausal · Osteoporosis

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 4

    CAT

    NCT06558188

    3 Feb 2025 to est. 19 Nov 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • RomosozumabDrug
  • TeriparatideDrug

Arms2

  • Active comparator

    Romosozumab

    romosozumab

  • Active comparator

    Romosozumab and Teriparatide

    romosozumab and teriparatide

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Lumbar spine areal bone mineral density

    Time frame · Month 0 to 12

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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