Teriparatide Treatment in Patients With Inherited Osteoporosis

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01360424
First received: May 6, 2011
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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


Condition Intervention Phase
Osteoporosis
Drug: Teriparatide
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Change from baseline in lumbar bone mineral density (BMD) [ Time Frame: 0, 12 and 24 months ] [ Designated as safety issue: No ]
    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:
  • Change from baseline in whole body bone mineral density (DXA) [ Time Frame: 0,12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in hip bone mineral density (DXA) [ Time Frame: 0,12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in histomorphometry of bone biopsy samples [ Time Frame: 0 and 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of vertebral fractures (spine X-ray) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in serum procollagen type I N-terminal propeptide (PINP) [ Time Frame: 0,3,6,12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in serum type I collagen C-telopeptides (CTX) [ Time Frame: 0,3,6,12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in serum osteocalcin [ Time Frame: 0,3,6,12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: May 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: teriparatide Drug: Teriparatide
Daily administration of teriparatide 20 ug s.c. for 24 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360424

Locations
Finland
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, FI-00029 HUS
Sponsors and Collaborators
Helsinki University Central Hospital
Eli Lilly and Company
Investigators
Principal Investigator: Matti Välimäki, MD,PhD Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Matti Välimäki, MD, PhD, Division of Endocrinology Department of Medicine Helsinki University Central Hospital, Helsinki, Finland
ClinicalTrials.gov Identifier: NCT01360424     History of Changes
Other Study ID Numbers: HUS-LTO-PTH, 2010-019297-32
Study First Received: May 6, 2011
Last Updated: May 25, 2011
Health Authority: Finland: Ethics Committee
Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
osteoporosis
teriparatide
bone turnover
New forms of inherited low-turnover osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014