P1NP (ng/ml) Change From Baseline.
| Group | Value (Percent change from baseline) |
|---|---|
| Concurrent (A) | 42 |
| Sequential (B) | 186 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataShort name PICS
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.
This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women. The intension is to provide other options for treatment than the current standard 2 year course of drug therapy. These options may lead to treatment where the two years of therapy are spread over several years.
Active comparator
A: 6 months both + 18 months oral only
Group A will receive 6 months of monthly oral ibandronate 150 mg, plus daily PTH 1-84, 1.4 mg; followed by 18 months of ibandronate only. Placebo injections will be given months 13-15. Calcium + Vitamin D supplements, plus multivitamins are provided.
Active comparator
B: (3 months injection + 9 months oral) x 2 years
Group B will receive 3 months of daily PTH 1-84, 1.4 mg; followed by 9 months of monthly oral ibandronate, 150 mg in year 1. In year 2, the group will receive another 3 months of daily PTH 1-84; followed by 9 months of monthly ibandronate. Placebo monthly pills will be given months 1-3 and months 13-15, and placebo injections will be given months 4-6. Calcium + Vitamin D supplements, plus multivitamins are provided.
Outcomes the sponsor listed as primary.
P1NP (ng/ml) Change From Baseline.
Time frame · Baseline, 3 months
After an overnight fast, serum was drawn at baseline and 1, 3, 6, 12, 15, 18 and 24 months. Samples were stored at -70C until batch assayed in a central laboratory. Serum N-propeptide of type I collagen (P1NP) and C-terminal telopeptide of type I collagen (CTX) were measured by electrochemiluminescent immunoassay. Bone-specified alkaline phosphate (BAP) was measured by paramagnetic particle immunoassay. P1NP was the bone turnover marker upon which we based sample size calculations.
Change From Baseline in Trabecular Spine vBMD
Time frame · Baseline, 24 months.
Areal bone mineral density (aBMD) at the lumbar spine, hip, and distal one-third radius was assessed by dual-energy X-ray absorption at baseline and 6, 12, 18, and 24 months. The precision for aBMD is 1.0%. Volumetric BMD and bone geometry in trabecular and cortical compartments were assessed by quantitative computed tomography (QCT) at the spine and hip. The left hip was used for analysis. The precision for trabecular spine vBMD measurement is 1.0%. Trabecular spine vBMD was our primary BMD outcome, thus the one presented here.
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) |
|---|---|
| Concurrent (A) | 42 |
| Sequential (B) | 186 |
| Group | Value (Percent change from baseline) | Spread |
|---|---|---|
| Concurrent (A) | 12.5 | 11.2 |
| Sequential (B) | 13.7 | 21.1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Concurrent (A)Concurrent Group (A) received 6 months of monthly oral ibandronate 150 mg plus daily PTH 1-84 1.4 mg, followed by 18 months of ibandronate only. Placebo injections were given months 13-15. | – | 0 / 22 | 21 / 22 |
| Sequential (B)Sequential Group (B) received 3 months of daily PTH 1-84 1.4 mg followed by 9 months of monthly oral ibandronate 150 mg in each of years 1 and 2. Placebo monthly pills were given months 1-3 and months 13-15, and placebo injections were given months 4-6. | – | 0 / 22 | 21 / 22 |
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.
2 studies on this page
Indexing hint: Randomized controlled trial · 2013
Schafer et al. 2013Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 22
PMID 23589163DOI 10.1007/s00198-013-2349-yPUB-23589163
Indexing hint: Randomized controlled trial · 2012
Schafer et al. 2012The Journal of clinical endocrinology and metabolismcited by 35
PMID 22791766PMC3674294DOI 10.1210/jc.2012-1844PUB-22791766
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