An observational study in Osteoporosis, Postmenopausal and Osteoporosis, sponsored by Eli Lilly and Company. Completed at 1 site in Italy. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2011-05-09.
Sponsored by Eli Lilly and Company · Observational
This observational study will evaluate the incidence of new vertebral and non vertebral fragility fractures in patients with severe osteoporosis treated with anabolic drugs. This study will also evaluate BMD, compliance to treatment, back pain and the health-related quality of life.
The participants should be treated with anabolic therapy for osteoporosis (Teriparatide or PTH 1-84) for 18 months and should be followed up for subsequent 6 months. The treatment is expected to improve bone mineral density, back pain and reduce the risk of new fractures due to osteoporosis. The outcomes will be evaluated by bone densitometry at the lumbar spine and femoral neck, by standard radiographs, by measurements of bone formation marker (P1NP) and by questionnaires on back pain and quality of life. Postmenopausal women and men over 21 years old may be included if they have:
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 794 is above the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Primary care clinic
Exclusion Criteria:
Postmenopausal women and men aged \> 21 years old affected by severe osteoporosis
Drug: Teriparatide
20 mcg daily subcutaneous for 18 months.
Incidence of any osteoporotic fractures in the first 24 months from the initiation of anabolic medication.
Time frame: From 0 to 24 months
Treatment compliance
Time frame: From 0 to 24 months
Reason of discontinuation
Time frame: From 0 to 24 months
BMD changes (lumbar and femoral BMD)
Time frame: From 0 to 24 months
Changes in bone turnover marker measured by P1NP
Time frame: From 0 to 24 months
Quality of Life (measured by EQ-5D of EuroQol Group)
Time frame: From 0 to 24 months
Back Pain measured by visual analogue scale and back pain questionnaire
Time frame: From 0 to 24 months
Assessment of motor performance and chair rising test
Time frame: From 0 to 24 months
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company