Treatment of osteogenesis imperfecta with parathyroid hormone and zoledronic acid

Phase 3

• Conditions: Osteogenesis imperfecta; Musculoskeletal Diseases; Osteogenesis Imperfecta

• Registration Number: ISRCTN15313991
• Lead Sponsor: niversity of Edinburgh

Brief Summary

2023 Protocol article in https://doi.org/10.1136/bmjopen-2023-078164 (added 23/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-10
• Last Update Posted: 4 December 2023
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Adult patients age 18 years and over with a clinical diagnosis of osteogenesis imperfecta
2. Patients willing and able to consent and comply with the study protocol

Exclusion Criteria

Current exclusion criteria as of 07/02/2017:
1. Current or previous treatment with an investigational (non-licensed) drug with effects on bone metabolism
2. Contraindication to TPTD or ZA
3. Women of childbearing potential not using highly effective methods of contraception
4. Pregnancy
5. Women that are breastfeeding
6. Age < 18 years

Previous exclusion criteria:
1. Contraindication to TPTD or ZA
2. Current or previous treatment with an investigational drug with effects on bone metabolism
3. Women of childbearing potential not using adequate contraception
4. Pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants experiencing a clinical fracture validated by x-ray or other imaging at the final study visit (between 36-60 months).