Change in Marker of Bone Metabolism, PINP
| Group | Value (Percent change from baseline) | Spread |
|---|---|---|
| Placebo | -13.1 | 26.47 |
| BA058 20 µg | 20.0 | 61.05 |
| BA058 40 µg | 90.8 | 116.92 |
| BA058 80 µg | 97.2 | 123.88 |
| Teriparatide | 154.3 | 213.07 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis
NCT00542425Apr 2007 to Jun 2009
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.
Placebo comparator
Placebo
Experimental
BA058 20 µg
Experimental
BA058 40 µg
Experimental
BA058 80 µg
Active comparator
teriparatide
Outcomes the sponsor listed as primary.
Change in Marker of Bone Metabolism, PINP
Time frame · 6 months
PINP, N-terminal propeptide of type I procollagen, is a marker of anabolic bone growth.
Change in Bone Mineral Density, Total Spine.
Time frame · 6 months
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 24.
Change in Bone Mineral Density, Femoral Neck.
Time frame · 6 months
Femoral neck bone mineral density (BMD) was analyzed by DXA at Week 24.
Change in Bone Mineral Density, Total Hip.
Time frame · 6 months
Total analyzable hip bone mineral density (BMD) was analyzed by DXA at Week 24.
Change in Bone Mineral Density, Total Spine.
Time frame · 12 months
Total analyzable spine bone mineral density (BMD) was analyzed by DXA at Week 48.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Percent change from baseline) | Spread |
|---|---|---|
| Placebo | -13.1 | 26.47 |
| BA058 20 µg | 20.0 | 61.05 |
| BA058 40 µg | 90.8 | 116.92 |
| BA058 80 µg | 97.2 | 123.88 |
| Teriparatide | 154.3 | 213.07 |
| Group | Value (Percent change from baseline) | Spread |
|---|---|---|
| Placebo | 1.22 | 3.211 |
| BA058 20 µg | 3.30 | 2.068 |
| BA058 40 µg | 5.21 | 4.427 |
| BA058 80 µg | 6.11 | 3.744 |
| Teriparatide | 5.47 | 4.218 |
| Group | Value (Percent change from baseline) | Spread |
|---|---|---|
| Placebo | 0.79 | 4.797 |
| BA058 20 µg | 2.69 | 4.022 |
| BA058 40 µg | 2.20 | 4.406 |
| BA058 80 µg | 3.07 | 4.175 |
| Teriparatide | 1.07 | 4.564 |
| Group | Value (Percent change from baseline) | Spread |
|---|---|---|
| Placebo | 0.39 | 3.053 |
| BA058 20 µg | 1.43 | 2.639 |
| BA058 40 µg | 1.97 | 3.699 |
| BA058 80 µg | 2.60 | 3.488 |
| Teriparatide | 0.45 | 3.925 |
| Group | Value (Percent change from baseline) | Spread |
|---|---|---|
| Placebo | 0.74 | 3.541 |
| BA058 20 µg | 5.14 | 3.164 |
| BA058 40 µg | 9.84 | 5.313 |
| BA058 80 µg | 12.94 | 3.251 |
| Teriparatide | 8.63 | 6.8 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebo | – | 1 / 45 | 30 / 45 |
| BA058 20 µg | – | 2 / 43 | 31 / 43 |
| BA058 40 µg | – | 0 / 43 | 32 / 43 |
| BA058 80 µg | – | 2 / 45 | 33 / 45 |
| Teriparatide | – | 0 / 45 | 35 / 45 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2015
Leder et al. 2015The Journal of clinical endocrinology and metabolismcited by 193
PMID 25393645DOI 10.1210/jc.2014-3718PUB-25393645
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated