Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)
| Group | Value (percentage of BMD change) | Spread |
|---|---|---|
| Women With Idiopathic Osteoporosis (IOP) | 10.8 | 8.3 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataShort name IOPForteo
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide \[PTH(1-34)\], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.
Experimental
Women with Idiopathic osteoporosis (IOP)
Each subject will receive 20 micrograms of Teriparatide (PTH 1-34) subcutaneously daily for 18 -24 months
Outcomes the sponsor listed as primary.
Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)
Time frame · Baseline, Month 18 or 24 reported
Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of BMD change) | Spread |
|---|---|---|
| Women With Idiopathic Osteoporosis (IOP) | 10.8 | 8.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Women With Idiopathic Osteoporosis (IOP)Each subject will receive 20 micrograms of teriparatide subcutaneously daily. Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18-24 months | 0 / 21 | 0 / 21 | 8 / 21 |
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