Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid

Phase 4

• Conditions: brittle bone disease; OI; 10027424; 10013296; 10005959

• Registration Number: NL-OMON55540
• Lead Sponsor: ACCORD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 50

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

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
• Study Design: Not specified