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Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis (RPM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01611571
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : March 4, 2014
Last Update Posted : March 4, 2014
Alliance for Better Bone Health
Information provided by (Responsible Party):
Marcella Walker, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Risedronate Drug: Teriparatide Drug: Placebo Teriparatide Drug: placebo Risedronate Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis
Study Start Date : December 2003
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Active Risedronate Placebo Teriparatide
Active Risedronate + Placebo Teriparatide for 18 months / Active Risedronate for 6 months
Drug: Risedronate
weekly risedronate
Other Names:
  • Actonel
  • Risedronic Acid

Drug: Placebo Teriparatide
daily placebo of teriparatide
Other Names:
  • Teriparatide
  • PTH1-34
  • Forteo

Active Comparator: Active Risedronate Active Teriparatide
Active Risedronate + Active Teriparatide for 18 months / Active Risedronate for 6 months
Drug: Risedronate
weekly risedronate
Other Names:
  • Actonel
  • Risedronic Acid

Drug: Teriparatide
daily teriparatide
Other Names:
  • PTH1-34
  • Forteo

Active Comparator: Placebo Risedronate Active Teriparatide
Placebo Risedronate Active Teriparatide for 18 months / Active Risedronate for 6 months
Drug: Teriparatide
daily teriparatide
Other Names:
  • PTH1-34
  • Forteo

Drug: placebo Risedronate
weekly placebo of Risedronic Acid
Other Names:
  • Risedronate
  • Risedronic Acid

Primary Outcome Measures :
  1. Change in Spine Bone Density [ Time Frame: 18 months ]
    change in spine bone density at 18 months measured by DXA 18 and 24 months

Secondary Outcome Measures :
  1. Change in Hip Bone Density [ Time Frame: baseline and 18 months ]
    change in hip bone density measured by DXA

  2. Change in Forearm Bone Density [ Time Frame: baseline and 18 months ]
    change in 1/3 radius of forearm bone density as measured by DXA

  3. 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

  4. Change in FN BMD at 18 Months [ Time Frame: 18 months ]
    Change in the Femoral Neck BMD at 18 month

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01611571

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United States, New York
Columbia University Medical Center, Harkness Pavilion
New York City, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Alliance for Better Bone Health
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Principal Investigator: Marcella Walker, MD Columbia University

Publications of Results:
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Responsible Party: Marcella Walker, Irving Assistant Professor of Clinical Medicine, Columbia University Identifier: NCT01611571     History of Changes
Other Study ID Numbers: AAAA4304
First Posted: June 5, 2012    Key Record Dates
Results First Posted: March 4, 2014
Last Update Posted: March 4, 2014
Last Verified: January 2014

Keywords provided by Marcella Walker, Columbia University:

Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Parathyroid Hormone
Risedronic Acid
Etidronic Acid
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action