Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis

NCT01611571 | Completed Phase 3 Results

• 1 other identifier: AAAA4304
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

osteoporosis; male

Outcome Measures

Primary Outcomes (1)

• Change in Spine Bone Density

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

  18 months

Secondary Outcomes (4)

• Change in Hip Bone Density

  baseline and 18 months

• Change in Forearm Bone Density

  baseline and 18 months

• New Morphometric Vertebral Fractures

  baseline through 18 months

• Change in FN BMD at 18 Months

  18 months

Study Arms (3)

Active Risedronate Placebo Teriparatide

ACTIVE COMPARATOR

Active Risedronate + Placebo Teriparatide for 18 months / Active Risedronate for 6 months

Drug: Risedronate; Drug: Placebo Teriparatide

Active Risedronate Active Teriparatide

ACTIVE COMPARATOR

Active Risedronate + Active Teriparatide for 18 months / Active Risedronate for 6 months

Drug: Risedronate; Drug: Teriparatide

Placebo Risedronate Active Teriparatide

ACTIVE COMPARATOR

Placebo Risedronate Active Teriparatide for 18 months / Active Risedronate for 6 months

Drug: Teriparatide; Drug: placebo Risedronate

Interventions

Risedronate DRUG

weekly risedronate

Also known as: Actonel, Risedronic Acid

Active Risedronate Active Teriparatide; Active Risedronate Placebo Teriparatide

Teriparatide DRUG

daily teriparatide

Also known as: PTH1-34, Forteo

Active Risedronate Active Teriparatide; Placebo Risedronate Active Teriparatide

Placebo Teriparatide DRUG

daily placebo of teriparatide

Also known as: Teriparatide, PTH1-34, Forteo

Active Risedronate Placebo Teriparatide

placebo Risedronate DRUG

weekly placebo of Risedronic Acid

Also known as: Risedronate, Risedronic Acid

Placebo Risedronate Active Teriparatide

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males, ages 30-85 with osteoporosis.
• Osteoporosis can be due to hypogonadism, past steroid use, or idiopathic.
• Patients with hypogonadism can be included if their replacement dosage of testosterone has been stable for at least 18 months.
• 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.
• Normal renal (glomerular filtration rate \>= 60 ml/min) and liver (less than or equal to twice the normal limits for ALT and AST) function.

You may not qualify if:

• Use of any specific osteoporosis drug in the previous 6 months.
• Known or suspected metabolic bone diseases (such as renal osteodystrophy, osteomalacia) other than osteoporosis.
• Preexisting hypercalcemia or an underlying hypercalcemic disorder, such as primary hyperparathyroidism.
• Secondary hyperparathyroidism.
• 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.
• Patients with any elevations of alkaline phosphatase that are secondary to bone disease, as such individuals may be at risk for osteosarcoma.
• History or presence of any malignancy, except dermatological, but including melanoma. Known or suspected bone metastasis, or a history of skeletal malignancies.
• Prior radiation therapy. Patients with prior radiation therapy should be excluded from treatment with teriparatide.
• 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.
• History of previous major bowel surgery including bowel resection.
• Oral use of systematic glucocorticoids for two or more weeks in the previous six months.
• Parenteral use of systemic glucocorticoids on more than two occasions in the previous six months.
• Use of anticonvulsant drugs.
• History of uncontrolled diabetes mellitus (Patient with Type 2 diabetes who have HbA1C\< 8 are permitted to be enrolled).
• Hypercalciuria (\> 4 mg/kg/day).

Sponsors & Collaborators

• Columbia University: lead
• Alliance for Better Bone Health: collaborator

Study Sites (1)

Columbia University Medical Center, Harkness Pavilion

New York, New York, 10032, United States

Location

Related Publications (1)

• Walker MD, Cusano NE, Sliney J Jr, Romano M, Zhang C, McMahon DJ, Bilezikian JP. Combination therapy with risedronate and teriparatide in male osteoporosis. Endocrine. 2013 Aug;44(1):237-46. doi: 10.1007/s12020-012-9819-4. Epub 2012 Oct 26.

  PMID: 23099796 RESULT

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid; Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Marcella Walker MD
• Organization: Columbia University Medical Center

mad2037@columbia.edu

212-342-5351

Study Officials

• Marcella Walker, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Irving Assistant Professor of Clinical Medicine

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 5, 2012
• Study Start: December 1, 2003
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 4, 2014
• Results First Posted: March 4, 2014

Record last verified: 2014-01

Locations

US (1)