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Completed

NCT Number: NCT01199094

Clinical Assessment of Patients With High Bone Mass Due to Mutation in Lrp5

The aim of the study is to describe patients with a high bone mass phenotype due to a mutation in the low density lipoprotein l receptor 5 gene (LRP5) and compare them with age and sex matched controls. Moreover, bone density and microarchitecture as well as markers of bone metabolism are evaluated

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Key information

Conditions

Osteopetrosis Bone Diseases Bone Diseases, Developmental Musculoskeletal Diseases Osteochondrodysplasias Osteopetrosis autosomal dominant type 1 Osteosclerosis

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Odense University Hospital, Osteoporosis Clinic

Odense, 5000, Denmark

About this study

Cases and controls are closely matched on age and sex and evaluated cross-sectionally.

Dual x-ray absorptiometry (DXA) and high resolution peripheral quantitative computed tomography (HR-pQCT) are used in order to evaluate bone density as well as microarchitecture. Bone turnover markers and body composition are also measured.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Lrp5 mutation/ADOI

Exclusion criteria

  • Pregnancy

Treatment and study plan

Primary outcomes

  1. Bone microarchitecture as assessed by high resolution quantitative computed tomography (HR-pQCT)

    Time frame: 12 weeks

    HR-pQCT is used to evaluate bone microarchitecture, i.e. bone trabeculae, cortical thickness and trabecular number. Aim is to test if the microarchitecture of these patients are different that observed in normal controls

Secondary outcomes

  1. Changes in bone turnover markers

    Time frame: 12 weeks

    Markers of bone resorption and formation are investigated.

  2. Bone mineral density

    Time frame: 12 weeks

    DXA is used to evaluate bone mineral density at total hip, spine, whole body and forearm.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

Clinical Assessment of Patients With High Bone Mass Due to Mutation in Low Density Lipoprotein l Receptor 5

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 10, 2010
Registry last updated
Sep 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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