Teriparatide Treatment in Patients With Inherited Osteoporosis

Study Overview
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Brief Summary
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The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.

Official Title
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Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: inherited low-turnover osteoporosis lumbar spine or hip BMD T-score ≤ -2.5 a written informed consent. Exclusion Criteria: age less than 18 years generally accepted contraindications for the treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: teriparatide<br> | Drug: Teriparatide<br>* Daily administration of teriparatide 20 ug s.c. for 24 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in lumbar bone mineral density (BMD) | The primary outcome measure is the change in lumbar BMD measured with dual-energy X-ray absorptiometry (DXA) during the 24 months treatment period. | 0, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in whole body bone mineral density (DXA) |  | 0,12 and 24 months | 
| Change from baseline in hip bone mineral density (DXA) |  | 0,12 and 24 months | 
| Change from baseline in histomorphometry of bone biopsy samples | includes e.g following parameters: Bone volume (BV/TV, %); Osteoid volume (OV/BV, %); Trabecular thickness (Tb.Th, um); Osteoid surface (OS/BS, %); Osteoblast surface (Ob.S/BS, %); Eroded surface (ES/BS, %); Osteoclast surface (Oc.S/BS, %); Mineral apposition rate (MAR, um/day); Mineralizing surface (MS/BS, %) | 0 and 24 months | 
| Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples | includes e.g following parameters: bone volume (BV, mm3); relative bone volume (BV/TV, %); connectivity density, (Conn.D., 1/mm3); trabecular number (DT-Tb.N, 1/mm); trabecular thickness (DT-Tb.Th, mm) | 0 and 24 months | 
| Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius |  | 0,12 and 24 months | 
| Number of vertebral fractures (spine X-ray) |  | 24 months | 
| Change from baseline in serum procollagen type I N-terminal propeptide (PINP) |  | 0,3,6,12 and 24 months | 
| Change from baseline in serum type I collagen C-telopeptides (CTX) |  | 0,3,6,12 and 24 months | 
| Change from baseline in serum osteocalcin |  | 0,3,6,12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, teriparatide, bone turnover, New forms of inherited low-turnover osteoporosis