Change in Spine Bone Density
| Group | Value (% change in LS BMD) | Spread |
|---|---|---|
| Active Risedronate Active Teriparatide | 6.95 | 1.9 |
| Active Risedronte Placebo Teriparatide | 3.76 | 1.8 |
| Placebo Risedronate Active Teriparatide | 5.68 | 1.9 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataShort name RPM
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.
The purpose of this study is to develop new treatment options for osteoporosis in men. The Investigators will study two medications and three treatment regimens. First, risedronate (FDA approved) will be studied as monotherapy. Second, the investigators will study injectable parathyroid hormone (PTH 134, teriparatide; FDA approved), as a therapy for male osteoporosis. PTH, a naturally occurring hormone produced by the parathyroid glands, is one of the most important regulators of bone metabolism. The drug being studied in this protocol, teriparatide, is the first aminoterminal 34 amino acids of the native 84amino acid peptide. Teriparatide contains all of the classical biological activities of native PTH. In studies of postmenopausal women, in a small study of 23 men with osteoporosis and a larger study of 437 men treatment with teriparatide led to significant increases in bone density. Although teriparatide and actonel are now approved for osteoporosis in men additional studies of these medications are needed in order to establish how best to use these drugs. This study is focused on an entirely new treatment approach, namely the combination of two medications for the treatment of osteoporosis risedronate with teriparatide to evaluate whether combination therapy is superior to therapy with either medication alone. This study is also designed to assess the extent to which risedronate maintains increases in bone density after a course of mono or combination therapy.
Active comparator
Active Risedronate Placebo Teriparatide
Active Risedronate + Placebo Teriparatide for 18 months / Active Risedronate for 6 months
Active comparator
Active Risedronate Active Teriparatide
Active Risedronate + Active Teriparatide for 18 months / Active Risedronate for 6 months
Active comparator
Placebo Risedronate Active Teriparatide
Placebo Risedronate Active Teriparatide for 18 months / Active Risedronate for 6 months
Outcomes the sponsor listed as primary.
Change in Spine Bone Density
Time frame · 18 months
change in spine bone density at 18 months measured by DXA 18 and 24 months
Change in Hip Bone Density
Time frame · baseline and 18 months
change in hip bone density measured by DXA
Change in Forearm Bone Density
Time frame · baseline and 18 months
change in 1/3 radius of forearm bone density as measured by DXA
New Morphometric Vertebral Fractures
Time frame · baseline through 18 months
counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study
Change in FN BMD at 18 Months
Time frame · 18 months
Change in the Femoral Neck BMD at 18 month
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (% change in LS BMD) | Spread |
|---|---|---|
| Active Risedronate Active Teriparatide | 6.95 | 1.9 |
| Active Risedronte Placebo Teriparatide | 3.76 | 1.8 |
| Placebo Risedronate Active Teriparatide | 5.68 | 1.9 |
| Group | Value (% change in TH BMD) | Spread |
|---|---|---|
| Active Risedronate Active Teriparatide | 3.86 | 1.1 |
| Active Risedronte Placebo Teriparatide | 0.82 | 0.95 |
| Placebo Risedronate Active Teriparatide | 0.29 | 0.95 |
| Group | Value (% change in 1/3 Radius BMD) | Spread |
|---|---|---|
| Active Risedronate Active Teriparatide | 1.6 | 0.6 |
| Active Risedronte Placebo Teriparatide | 0.11 | 0.77 |
| Placebo Risedronate Active Teriparatide | 0.02 | 0.77 |
| Group | Value (vertebral fracture) |
|---|---|
| Active Risedronate Active Teriparatide | 1 |
| Active Risedronte Placebo Teriparatide | 1 |
| Placebo Risedronate Active Teriparatide | 0 |
| Group | Value (% change in TH BMD) | Spread |
|---|---|---|
| Active Risedronate Active Teriparatide | 8.45 | 1.8 |
| Active Risedronte Placebo Teriparatide | 0.5 | 1.7 |
| Placebo Risedronate Active Teriparatide | 3.89 | 1.7 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Active Risedronate Active TeriparatideActive Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide | – | 0 / 10 | 6 / 10 |
| Active Risedronte Placebo TeriparatideActive Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo) | – | 0 / 10 | 3 / 10 |
| Placebo Risedronate Active Teriparatide, Active RisedronatePlacebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months | – | 0 / 9 | 2 / 9 |
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 · 2013
Walker et al. 2013Endocrinecited by 63
PMID 23099796DOI 10.1007/s12020-012-9819-4PUB-23099796
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