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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis

Short name RPM

Overview

Status
Completed
Phase
Phase 3
Enrollment
31 participants (actual)
Sponsor
Columbia University · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Dec 2003
Primary completion
Nov 2011
Completion
Nov 2011
First posted
5 Jun 2012 (estimated)
Last update posted
4 Mar 2014 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042006200820102012
  1. Ph 3

    RPM

    NCT01611571

    Dec 2003 to Nov 2011

Registry summary

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.

Interventions

  • RisedronateDrug
  • TeriparatideDrug
  • Placebo TeriparatideDrug
  • placebo RisedronateDrug

Arms3

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Spine Bone Density

    Time frame · 18 months

    Registry description

    change in spine bone density at 18 months measured by DXA 18 and 24 months

Secondary outcomes(4)
  1. Change in Hip Bone Density

    Time frame · baseline and 18 months

    Registry description

    change in hip bone density measured by DXA

  2. Change in Forearm Bone Density

    Time frame · baseline and 18 months

    Registry description

    change in 1/3 radius of forearm bone density as measured by DXA

  3. New Morphometric Vertebral Fractures

    Time frame · baseline through 18 months

    Registry description

    counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study

  4. Change in FN BMD at 18 Months

    Time frame · 18 months

    Registry description

    Change in the Femoral Neck BMD at 18 month

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· 18 months

Change in Spine Bone Density

GroupValue (% change in LS BMD)Spread
Active Risedronate Active Teriparatide6.951.9
Active Risedronte Placebo Teriparatide3.761.8
Placebo Risedronate Active Teriparatide5.681.9
Secondary and other outcome results(4)
Secondary outcomeMean· baseline and 18 months

Change in Hip Bone Density

GroupValue (% change in TH BMD)Spread
Active Risedronate Active Teriparatide3.861.1
Active Risedronte Placebo Teriparatide0.820.95
Placebo Risedronate Active Teriparatide0.290.95
Secondary outcomeMean· baseline and 18 months

Change in Forearm Bone Density

GroupValue (% change in 1/3 Radius BMD)Spread
Active Risedronate Active Teriparatide1.60.6
Active Risedronte Placebo Teriparatide0.110.77
Placebo Risedronate Active Teriparatide0.020.77
Secondary outcomeNumber· baseline through 18 months

New Morphometric Vertebral Fractures

GroupValue (vertebral fracture)
Active Risedronate Active Teriparatide1
Active Risedronte Placebo Teriparatide1
Placebo Risedronate Active Teriparatide0
Secondary outcomeMean· 18 months

Change in FN BMD at 18 Months

GroupValue (% change in TH BMD)Spread
Active Risedronate Active Teriparatide8.451.8
Active Risedronte Placebo Teriparatide0.51.7
Placebo Risedronate Active Teriparatide3.891.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Active Risedronate Active TeriparatideActive Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide–0 / 106 / 10
Active Risedronte Placebo TeriparatideActive Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)–0 / 103 / 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 / 92 / 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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2013

13 results

Combination therapy with risedronate and teriparatide in male osteoporosis.

Walker et al. 2013Endocrinecited by 63

PMID 23099796DOI 10.1007/s12020-012-9819-4PUB-23099796

Rights unknown13 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 30 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Males, ages 30-85 with osteoporosis. 2. Osteoporosis can be due to hypogonadism, past steroid use, or idiopathic. 3. Patients with hypogonadism can be included if their replacement dosage of testosterone has been stable for at least 18 months. 4. Bone mineral density must be 2 or more standard deviations below (T-score 2.0) the young adult peak for men at the lumbar spine, the hip or the radius. 5. Normal renal (glomerular filtration rate \>= 60 ml/min) and liver (less than or equal to twice the normal limits for ALT and AST) function. Exclusion Criteria: 1. Use of any specific osteoporosis drug in the previous 6 months. 2. Known or suspected metabolic bone diseases (such as renal osteodystrophy, osteomalacia) other than osteoporosis. 3. Preexisting hypercalcemia or an underlying hypercalcemic disorder, such as primary hyperparathyroidism. 4. Secondary hyperparathyroidism. 5. Paget's disease of bone or fibrous dysplasia. Teriparatide should not be given to patients with these conditions due to an increased risk of osteosarcoma. 6. Patients with any elevations of alkaline phosphatase that are secondary to bone disease, as such individuals may be at risk for osteosarcoma. 7. History or presence of any malignancy, except dermatological, but including melanoma. Known or suspected bone metastasis, or a history of skeletal malignancies. 8. Prior radiation therapy. Patients with prior radiation therapy should be excluded from treatment with teriparatide. 9. Any medical condition, which in the opinion of the investigator could preclude study participation, including but not limited to cardiovascular, gastric, renal and hepatic disorders, or abnormal PSA test. In particular, patients with active or recent (within the last 2 years) urolithiasis will be excluded. 10. History of previous major bowel surgery including bowel resection. 11. Oral use of systematic glucocorticoids for two or more weeks in the previous six months. 12. Parenteral use of systemic glucocorticoids on more than two occasions in the previous six months. 13. Use of anticonvulsant drugs. 14. History of uncontrolled diabetes mellitus (Patient with Type 2 diabetes who have HbA1C\< 8 are permitted to be enrolled). 15. Hypercalciuria (\> 4 mg/kg/day). 16. Impaired liver function (\>twice the upper normal limits for ALT and AST). 17. Hyperadrenalism as assessed by physical examination. 18. Any other clinically significant laboratory abnormalities, which are deemed relevant to the design of the protocol. 19. Patients with known hypersensitivity to any of the test materials (teriparatide or risedronate) or related components (metacresol, mannitol, glacial acetic acid, sodium acetate). 20. Use of any investigational or unlicensed drug in the previous 30 days. 21. Patients who may be unreliable for the study, including those engaging in excessive alcohol consumption or drug abuse or patients who are unable to return for scheduled follow-up visits. 22. Patients who are unable or unwilling to comply fully with the protocol. 23. Inability to stand or sit upright for at least 30 minutes 24. Those with history of esophagitis, Barrett's esophagus, esophageal/peptic ulcers or esophageal motility disorders 25. Hypocalcaemia 26. Renal dysfunction (GFR \<60) 27. Patients planning invasive dental work such as implants, extractions or procedures involving the jaw bone or patients with poor oral hygiene 28. Use of digitalis. 29. Patients with HIV/AIDS.

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