Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]; Osteogenesis imperfecta; MedDRA version: 20.0Level: PTClassification code 10031243Term: Osteogenesis imperfectaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders

• Registration Number: EUCTR2016-003228-22-IE
• Lead Sponsor: niversity of Edinburgh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-03
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

Adult patients age 18 years and above with a clinical diagnosis of OI

Patients willing and able to consent and comply with the study protocol

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

•Current or previous treatment with an investigational (non-licensed) drug with effects on bone metabolism.

•Contraindication to TPTD or ZA

•Women of childbearing potential not using highly effective methods of contraception (see below)

•Pregnancy

•Women that are breastfeeding

•Age <18 years

Women of childbearing potential (WOCBP) can be enrolled into the study but will be required to use highly effective methods of contraception (as defined by the HMA Clinical Trial Facilitation Group recommendations) before, during the trial if they are being treated with TPTD or bisphosphonates. Examples of highly effective contraception include:
•Established use of oral, injected or implanted hormonal methods of contraception.
•Placement of an intrauterine device (IUD) or intrauterine system (IUS).
•Bilateral tubal occlusion
•Vasectomised partner
True abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps with or without spermicidal foam/gel/film/cream/suppository) are not considered to be highly effective methods of contraception

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified