Trial intelligence / Profile preview

OsteoBor in Postmenopausal Osteoporosis

NCT06809816Phase 2

Key facts

Status
Not yet recruiting
Start
Mar 2025
Primary completion
Aug 2025
Sponsor
Tabriz University of Medical Sciences
Modality
Small Molecules
Conditions
postmenopausal osteoporosis
01

Overview

Phase 2, randomised, double-blind trial in postmenopausal osteoporosis comparing OsteoBor Arm with Placebo Arm (2 arms). Primary endpoint: Percentage change in areal bone mineral density at 12 months. Planned start Mar 2025; status: not yet recruiting.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • OsteoBor Arm

    Sodium pentaborate pentahydrate + Standard of Care

  • Placebo Arm

    Placebo + Standard of Care

03

Who it enrols

Postmenopausal women aged 45-85 with osteoporosis (T-score <= -2.5 but > -3.5) and no history of hip or multiple spine fractures.

04

Endpoints

Primary

  • Percentage change in areal bone mineral density

Secondary

  • Percentage change in areal bone mineral density at the total hip and femoral neck

  • Serum Osteocalcin

  • Bone-specific alkaline phosphatase

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