Treatment of Osteogenesis Imperfecta With Parathyroid Hormone and Zoledronic Acid

Who is this study for? Adult patients with Osteogenesis Imperfecta
Status: Completed
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Osteogenesis imperfecta (OI) is an inherited skeletal disorder characterised by increased risk of fragility fractures. Bisphosphonates are frequently prescribed for adult patients with OI with the aim of preventing fractures but the evidence base for efficacy is poor. Recent evidence suggests that the bone anabolic agent teriparatide (TPTD) increases bone mineral density (BMD) and may have the potential to prevent fractures in OI. The purpose of the TOPaZ Trial is to investigate if a a two-year course of teriparatide (TPTD) followed by antiresorptive therapy with a single infusion of zoledronic acid (ZA) in adults with OI reduces the proportion of patients who experience a fracture as compared with standard care Adult patients with a clinical diagnosis of OI who are willing and able to give informed consent and who do not have contraindications to the study medications will be recruited from participating sites. Participants will be randomised 1:1 to receive either standard care for the duration of the trial or TPTD for 24 months followed by a single infusion of ZA, or another antiresorptive agent in the event that ZA is contraindicated. Participants will attend recruiting centres for a Baseline/Screening visit, at 12 months, 24 months and at the end of the trial for formal study visits with telephone calls every 6 months from a site research nurse. Participants randomised to TPTD will also attend recruiting centre at regular intervals during the 24 month treatment period to collect new supplies of TPTD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients aged 18 years and over with a clinical diagnosis of Osteogenesis Imperfecta (OI)

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

Locations
Other Locations
Ireland
St Vincent's Hospital
Dublin
United Kingdom
Aberdeen Royal Infirmary
Aberdeen
Royal Victoria Hospital
Belfast
Queen Elizabeth Hospital
Birmingham
Bristol Royal Infirmary
Bristol
Addenbrooke's Hospital
Cambridge
Ninewells Hospital
Dundee
Western General Hospital
Edinburgh
Queen Elizabeth University Hospital
Glasgow
Leicester Royal Infirmary
Leicester
Royal Liverpool Hospital and Aintree Hospital
Liverpool
Llandough University Hospital
Llandough
Guy's and St Thomas' Hospital
London
Manchester Royal Infirmary
Manchester
James Cook University Hospital
Middlesbrough
Freeman Hospital
Newcastle Upon Tyne
Nottingham City Hospital
Nottingham
Nuffield Orthopaedic Centre
Oxford
Northern General Hospital
Sheffield
University Hospital Southampton
Southampton
Royal National Orthopaedic Hospital
Stanmore
Haywood Community Hospital
Stoke-on-trent
Wishaw General Hospital
Wishaw
Time Frame
Start Date: 2016-11-01
Completion Date: 2025-03-21
Participants
Target number of participants: 350
Treatments
Active_comparator: Teriparatide and zoledronic acid
Teriparatide (TPTD) 20mcg daily using Teriparatide Pen Injector, given subcutaneously using a self-administered injection device for two years (24 months) followed by a single intravenous 5mg infusion of zoledronic acid.
No_intervention: Standard Care
Continuation of existing bone modifying treatment (i.e. bisphosphonate treatment) or no active bone modifying treatment according to the clinical judgement of the local investigator.
Sponsors
Collaborators: NHS Lothian
Leads: University of Edinburgh

This content was sourced from clinicaltrials.gov