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Teriparatide Treatment in Patients With Inherited Osteoporosis

Information source: Helsinki University Central Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Teriparatide (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Helsinki University Central Hospital

Official(s) and/or principal investigator(s):
Matti Välimäki, MD,PhD, Principal Investigator, Affiliation: Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital

Summary

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

Clinical Details

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

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change from baseline in lumbar bone mineral density (BMD)

Secondary outcome:

Change from baseline in whole body bone mineral density (DXA)

Change from baseline in hip bone mineral density (DXA)

Change from baseline in histomorphometry of bone biopsy samples

Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples

Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius

Number of vertebral fractures (spine X-ray)

Change from baseline in serum procollagen type I N-terminal propeptide (PINP)

Change from baseline in serum type I collagen C-telopeptides (CTX)

Change from baseline in serum osteocalcin

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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 FI-00029 HUS, Finland
Additional Information

Starting date: May 2011
Last updated: May 25, 2011

Page last updated: August 20, 2015

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