Teriparatide Treatment in Patients With Inherited Osteoporosis
Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis
2 other identifiers
interventional
6
1 country
1
Brief Summary
The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 6, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedSeptember 29, 2015
September 1, 2015
2.5 years
May 6, 2011
September 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in lumbar bone mineral density (BMD)
The primary outcome measure is the change in lumbar BMD measured with dual-energy X-ray absorptiometry (DXA) during the 24 months treatment period.
0, 12 and 24 months
Secondary Outcomes (9)
Change from baseline in whole body bone mineral density (DXA)
0,12 and 24 months
Change from baseline in hip bone mineral density (DXA)
0,12 and 24 months
Change from baseline in histomorphometry of bone biopsy samples
0 and 24 months
Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples
0 and 24 months
Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius
0,12 and 24 months
- +4 more secondary outcomes
Study Arms (1)
teriparatide
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- inherited low-turnover osteoporosis
- lumbar spine or hip BMD T-score ≤ -2.5
- a written informed consent.
You may not qualify if:
- age less than 18 years
- generally accepted contraindications for the treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helsinki University Central Hospitallead
- Eli Lilly and Companycollaborator
Study Sites (1)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matti Välimäki, MD,PhD
Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
May 6, 2011
First Posted
May 25, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
September 29, 2015
Record last verified: 2015-09