Teriparatide Treatment in Patients With Inherited Osteoporosis

Phase 4

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Teriparatide

• Registration Number: NCT01360424
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-06
• Study First Submitted QC: 2011-05-24
• Study First Posted: 2011-05-25
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-27
• Last Update Posted: 2015-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
teriparatide	Teriparatide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	0 and 24 months	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, %)
Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples	0 and 24 months	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)
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

Trial Locations

Locations (1)

Department of Orthopaedics and Traumatology and Division of Endocrinology, Department of Medicine and Pediatric Endocrinology, Hospital for Children and Adolescents, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland