Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP) (NCT04181164) | Clinical Trial Compass
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Evaluation of Bone Architecture and Bone Strength in Adults With Hypophosphatasia (HPP)
Denmark30 participantsStarted 2019-10-01
Plain-language summary
The study aims to evaluate the bone architecture and bone strength in adults with Hypophosphatasia (HPP).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria HPP-Group:
* Genetically verified HPP
* Age: ≥ 18 years
* Persistently low levels of alkaline phosphatase (ALP) ≤ 35 U/L (normal range 35-105 U/L)
* At least one of the following symptoms: a) dental manifestations; b) musculoskeletal pain; c) history of fracture(s)
* Submitted informed consent
Inclusion Criteria Control-Group:
* No ALP measurements ≤ 45 U/l and ≥ 50% of all ALP measurements, registered in the electronical clinical journal ≥ 55 U/l
* Normal parathyroid hormone (PTH) and Pyridoxal-5´-phosphate (PLP)
* Vitamin D3 ≥ 25 nmol/L
* Submitted informed consent
Exclusion criteria HPP-Group:
* Pregnancy
* Skin infection or severe skin affection in the measurement area of microindentation
* Known allergy to Lidocain
* Former or current medical treatment influencing bone metabolism (oral corticosteroid \> 12 weeks, former or current anti-osteoporosis treatment at any time (regardless drug holiday), all kind of sex steroids (excluding oral contraception), anti-convulsants)
* Current malignant disorders
Exclusion Criteria Control-Group:
* Family history of a genetic metabolic bone disease (HPP, Osteogenesis imperfecta)
* Rickets in childhood
* Former or current Osteoporosis
* Former or current Osteomalacia
* Known diabetes
* Former or current medical treatment influencing bone metabolism (oral corticosteroid \> 12 weeks, former or current anti-osteoporosis treatment at any time (regardless drug holiday), all kind of sex steroids (excluding oral cont…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differences in Bone Mineral Strength Index (BMSi) between the two groups, assessed by microindentation (OsteoProbe®).