The Haemophilia Osteoporosis Registry (THOR): Identifying Mechanisms of Bone Loss in Haemophilia

Not Applicable

Recruiting

• Conditions: Haemophilia A; Osteoporosis; Sarcopenia; Osteoarthritis; Blood - Clotting disorders; Musculoskeletal - Osteoporosis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12621001397808
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-15
• Last Update Posted: 26 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 176

Inclusion Criteria

Eligibility for inclusion as a participant in this study will require a potential participant to satisfy all of the following eligibility criteria:
- Aged 18 years or older
- Male
- Body weight less than 160 kg (maximum rating of imaging machines).
- At least one side of the body must be free from any metal, or other material in limbs or surrounding locations, that could interfere with imaging.
- Fluent in written and spoken English, has capacity to provide informed consent and can communicate effectively with researchers. A legally acceptable representative and/or impartial witness fluent in written and spoken English and the participant’s first/fluent language acting as translator will also be acceptable, providing they are able to attend all scheduled sessions with the participant.

Patients with haemophilia recruited for the study should also satisfy the additional criterion below:
- Previously diagnosed with moderate to severe haemophilia A

Participants in the control group should also satisfy the additional criteria below:
- Be in good health without any major medical co-morbidities (diabetes, chronic kidney disease and recent cardiovascular events – stroke, myocardial infarction or heart attack)
- No other medical condition that in the opinion of the investigators may deem inclusion unsafe or inappropriate (e.g., recent exposure to nuclear medicine; conditions that may reduce ability to remain supine during DXA (e.g., vertigo); conditions that may reduce ability to remain still during scans (e.g. Parkinson’s disease, motor-neuron disease).
- Not be on medications that targets bone health e.g., Alendronate (Fosamax), Risedronate (Actonel), Ibandronate (Boniva), Zoledronate (Aclasta), Denosumab (Prolia), Teriparatide (Forteo) and Romosozumab (Evenity).

Exclusion Criteria

For all participants:
- Have other medical condition that in the opinion of the investigators may deem inclusion unsafe or inappropriate (e.g., recent exposure to nuclear medicine; conditions that may reduce ability to remain supine during DXA (e.g., vertigo); conditions that may reduce ability to remain still during scans (e.g. Parkinson’s disease, motor-neuron disease).

Control participants:
- On medications that targets bone health e.g., Alendronate (Fosamax), Risedronate (Actonel), Ibandronate (Boniva), Zoledronate (Aclasta), Denosumab (Prolia), Teriparatide (Forteo) and Romosozumab (Evenity).

Study & Design

• Study Type: Observational
• Study Design: Not specified