Skip to main content
OpenTrials
Completed

NCT Number: NCT01360424

Teriparatide Treatment in Patients With Inherited Osteoporosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

Daily administration of teriparatide 20 ug s.c. for 24 months

Primary outcomes

  1. 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 outcomes

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

    Time frame: 0,12 and 24 months

  2. Change from baseline in hip bone mineral density (DXA)

    Time frame: 0,12 and 24 months

  3. 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, %)

  4. 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)

  5. 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

  6. Number of vertebral fractures (spine X-ray)

    Time frame: 24 months

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

    Time frame: 0,3,6,12 and 24 months

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

    Time frame: 0,3,6,12 and 24 months

  9. Change from baseline in serum osteocalcin

    Time frame: 0,3,6,12 and 24 months

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 25, 2011
Registry last updated
Sep 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.