Alendronate and/or Parathyroid Hormone for Osteoporosis

NCT ID: NCT00000400

Last Updated: 2013-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-08-31
• Study Completion Date: 2006-06-30

Brief Summary

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.

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.

Conditions

Osteoporosis

Keywords

Osteoporosis; Bone formation; Bone resorption; Parathyroid hormone (PTH); Postmenopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PTH

Human parathyroid hormone \[hPTH-(1-34)\]

Group Type: EXPERIMENTAL

Human parathyroid hormone [hPTH-(1-34)]

Intervention Type: DRUG

37 mcg once daily by self-administered sc injection

ALN

Alendronate

Group Type: ACTIVE_COMPARATOR

alendronate

Intervention Type: DRUG

70 mg/week by oral route

PTH+ALN

Human parathyroid hormone \[hPTH-(1-34)\] plus alendronate

Group Type: EXPERIMENTAL

Human parathyroid hormone [hPTH-(1-34)]

Intervention Type: DRUG

37 mcg once daily by self-administered sc injection

alendronate

Intervention Type: DRUG

70 mg/week by oral route

Interventions

Human parathyroid hormone [hPTH-(1-34)]

37 mcg once daily by self-administered sc injection

Intervention Type: DRUG

alendronate

70 mg/week by oral route

Intervention Type: DRUG

Other Intervention Names

teriparatide; Fosamax

Eligibility 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robert M. Neer, MD

Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert M. Neer, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Finkelstein JS, Wyland JJ, Leder BZ, Burnett-Bowie SM, Lee H, Juppner H, Neer RM. Effects of teriparatide retreatment in osteoporotic men and women. J Clin Endocrinol Metab. 2009 Jul;94(7):2495-501. doi: 10.1210/jc.2009-0154. Epub 2009 Apr 28.

Reference Type: DERIVED

PMID: 19401368 (View on PubMed)

Related Links

http://www.mgh.harvard.edu

Click here for more information about this study.

Other Identifiers

P50AR044855

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50 AR44855 NIAMS-023

Identifier Type: -

Identifier Source: org_study_id