Teriparatide Treatment in Patients With Inherited Osteoporosis

Overview

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

Full Title of Study: “Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

Interventions

  • Drug: Teriparatide
    • Daily administration of teriparatide 20 ug s.c. for 24 months

Arms, Groups and Cohorts

  • Experimental: teriparatide

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in lumbar bone mineral density (BMD)
    • Time Frame: 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 Measures

  • Change from baseline in whole body bone mineral density (DXA)
    • Time Frame: 0,12 and 24 months
  • Change from baseline in hip bone mineral density (DXA)
    • Time Frame: 0,12 and 24 months
  • Change from baseline in histomorphometry of bone biopsy samples
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 0,12 and 24 months
  • Number of vertebral fractures (spine X-ray)
    • Time Frame: 24 months
  • Change from baseline in serum procollagen type I N-terminal propeptide (PINP)
    • Time Frame: 0,3,6,12 and 24 months
  • Change from baseline in serum type I collagen C-telopeptides (CTX)
    • Time Frame: 0,3,6,12 and 24 months
  • Change from baseline in serum osteocalcin
    • Time Frame: 0,3,6,12 and 24 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Helsinki University Central Hospital
  • Collaborator
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ville-Valtteri Välimäki, Dr – Helsinki University Central Hospital
  • Overall Official(s)
    • Matti Välimäki, MD,PhD, Principal Investigator, Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.