Teriparatide Treatment in Patients With Inherited Osteoporosis
This study is enrolling participants by invitation only.
Sponsor:
Helsinki University Central Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 23, 2013