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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014