Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial
| Group | Value (percent change) | Spread |
|---|---|---|
| PTH(1-84) | 446.1 | 355.3 |
| Strontium Ranelate | -6.2 | 36.9 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataDenmark
1 trial · 1 completed · 1 with posted results
Effect of Full Length Parathyroid Hormone, PTH(1-84) or Strontium Ranelate on Bone Markers in Postmenopausal Women With Primary Osteoporosis (FP-006-IM)
NCT00479037Apr 2007 to Jul 2009
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary objective of this trial is to show that PTH(1-84) is superior to strontium ranelate in bone formation measured as changes in bone formation markers over a treatment period of 24 weeks in postmenopausal women with primary osteoporosis.
Active comparator
PTH(1-84)
Active comparator
Strontium Ranelate
Outcomes the sponsor listed as primary.
Percentage Change in the Bone Formation Marker N-terminal Propeptides of Human Procollagen Type I (P1NP) From Baseline to End of Trial
Time frame · Baseline and 24 weeks of treatment
P1NP is a bone formation marker that is derived from the amino-terminal propeptides of type I collagen and is considered a quantitative measure of newly formed type I collagen. Bone marker measurements were done by blood analysis.
Percentage Change in the Bone Formation Marker Bone Specific Alkaline Phosphatase (BSAP) From Baseline to End of Trial
Time frame · Baseline and 24 weeks of treatment
BSAP is a marker of bone formation that reflects the cellular activity of osteoblasts. Bone marker measurements were done by blood analysis.
Percentage Change in the Bone Resorption Marker C-Telopeptide Cross-links (CTX) From Baseline to End of Trial
Time frame · Baseline and 24 weeks of treatment
CTX is a marker of bone resorption, which is a degradation product of bone collagen. Bone marker measurements were done by blood analysis.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percent change) | Spread |
|---|---|---|
| PTH(1-84) | 446.1 | 355.3 |
| Strontium Ranelate | -6.2 | 36.9 |
| Group | Value (percent change) | Spread |
|---|---|---|
| PTH(1-84) | 129.6 | 100.3 |
| Strontium Ranelate | 4.9 | 22.9 |
| Group | Value (percent change) | Spread |
|---|---|---|
| PTH(1-84) | 153.3 | 132.4 |
| Strontium Ranelate | -3.7 | 36.0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| PTH(1-84)Once daily subcutaneous injection | – | 2 / 40 | 29 / 40 |
| Strontium RanelateOne sachet (2 g) per day, suspended in water | – | 2 / 40 | 19 / 40 |
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.
No study cites this trial.
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