Osteoporosis
Conditions
Keywords
osteoporosis, teriparatide, bone turnover, New forms of inherited low-turnover osteoporosis
Brief summary
The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.
Interventions
DRUGTeriparatide
Daily administration of teriparatide 20 ug s.c. for 24 months
Sponsors
Eli Lilly and Company
Helsinki University Central Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in lumbar bone mineral density (BMD) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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) |
| 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 | — |
| Change from baseline in whole body bone mineral density (DXA) | 0,12 and 24 months | — |
| Change from baseline in serum procollagen type I N-terminal propeptide (PINP) | 0,3,6,12 and 24 months | — |
| Change from baseline in serum type I collagen C-telopeptides (CTX) | 0,3,6,12 and 24 months | — |
| Change from baseline in serum osteocalcin | 0,3,6,12 and 24 months | — |
| Number of vertebral fractures (spine X-ray) | 24 months | — |
Countries
Finland
Outcome results
None listed