Alendronate and/or Parathyroid Hormone for Osteoporosis - Full Text View

Purpose

This study looks at the effects of two medications, alendronate and parathyroid hormone, on bone mass and on bone formation and bone breakdown in women with osteoporosis. We will randomly select postmenopausal women who have osteoporosis to receive laboratory-produced human parathyroid hormone (hPTH), or alendronate, or both for 2.5 years. Study participants will return to the study center periodically to have their bone mass measured and to give blood and urine samples for tests of bone formation and breakdown and for other laboratory tests. Those who complete the study are eligible for one or two 12 month extension studies.

Condition	Intervention	Phase
Osteoporosis	Drug: Human parathyroid hormone [hPTH-(1-34)] Drug: alendronate	Phase II

MedlinePlus related topics:

Minerals Osteoporosis

Drug Information available for:

Parathyroid Alendronate Alendronate sodium Teriparatide Teriparatide acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Bone Formation-Resorption Coupling and Osteoporosis

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

change in spine bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

change in hip bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ] [ Designated as safety issue: No ]
change in forearm bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ] [ Designated as safety issue: No ]
change in total body bone mineral [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ] [ Designated as safety issue: No ]
change in femoral shaft bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ] [ Designated as safety issue: No ]
change in serum PINP [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ] [ Designated as safety issue: No ]
change in serum osteocalcin [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ] [ Designated as safety issue: No ]
change in serum NTX [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ] [ Designated as safety issue: No ]
incidence of hypercalcemia [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ] [ Designated as safety issue: Yes ]
incidence of hypercalciuria [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ] [ Designated as safety issue: Yes ]
incidence of symptoms [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ] [ Designated as safety issue: Yes ]

Enrollment:	176
Study Start Date:	August 1999
Study Completion Date:	June 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PTH: Experimental Human parathyroid hormone [hPTH-(1-34)]	Drug: Human parathyroid hormone [hPTH-(1-34)] 37 mcg once daily by self-administered sc injection
ALN: Active Comparator Alendronate	Drug: alendronate 70 mg/week by oral route
PTH+ALN: Experimental Human parathyroid hormone [hPTH-(1-34)] plus alendronate	Drug: Human parathyroid hormone [hPTH-(1-34)] 37 mcg once daily by self-administered sc injection Drug: alendronate 70 mg/week by oral route

Detailed Description:

This is a randomized, prospective, open-label study in which osteoporotic postmenopausal women self-administer synthetic hPTH-(1-34), alendronate, or both, every day for 2.5 years. Participants initially come to Massachusetts General Hospital once a month, and subsequently once every 3-6 months, for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass. One-third of the participants take hPTH-(1-34) daily, one-third take alendronate once daily, and one-third take both daily (Phase A, months 0-30).

Participants who complete Phase A are eligible for a 12 month extension study (Phase B, months 30-42), during which any alendronate treatment is continued without change and any hPTH 1-34 treatment is stopped.

Participants who complete Phase B are eligible for a second 12 month extension study (Phase C, months 42-54), during which any alendronate treatment is continued without change and every participant takes hPTH 1-34.

During Phases B and C, these participants come to Massachusetts General Hospital once every 6 months for measurements of serum and urine indices of bone formation and resorption, serum and urine toxicity tests, and DXA/QCT measurements of bone mass.

Eligibility

Ages Eligible for Study:	45 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Lumbar spine or hip BMD T-score less than or equal to minus 2.0
Postmenopausal at least 5 years
Fully ambulatory
Able to give informed consent

Exclusion Criteria:

No concurrent illnesses that cause bone loss
No recent drug treatment for osteoporosis
No recent fracture

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000400

Locations


United States, Massachusetts
	Massachusetts General Hospital
	Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators


Principal Investigator:	Robert M. Neer, MD	Massachusetts General Hospital

More Information

Click here for more information about this study. This link exits the ClinicalTrials.gov site

Responsible Party:	Endocrine Unit, Massachusetts General Hospital ( Robert M. Neer, MD )
Study ID Numbers:	P50 AR44855 NIAMS-023
First Received:	November 3, 1999
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00000400
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Osteoporosis

Bone formation

Bone resorption

Parathyroid hormone (PTH)

Postmenopause

Study placed in the following topic categories:

Musculoskeletal Diseases

Bone Resorption

Teriparatide

Alendronate

Osteoporosis

Bone Diseases, Metabolic

Bone Diseases

Additional relevant MeSH terms:

Physiological Effects of Drugs

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00000400