Alendronate and/or Parathyroid Hormone for Osteoporosis

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00000400

Collaborator

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

176

Enrollment

Location

Arms

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: Human parathyroid hormone [hPTH-(1-34)] Drug: alendronate	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Bone Formation-Resorption Coupling and Osteoporosis

Study Start Date :

Aug 1, 1999

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PTH Human parathyroid hormone [hPTH-(1-34)]	Drug: Human parathyroid hormone [hPTH-(1-34)] 37 mcg once daily by self-administered sc injection Other Names: teriparatide
Active Comparator: ALN Alendronate	Drug: alendronate 70 mg/week by oral route Other Names: Fosamax
Experimental: PTH+ALN Human parathyroid hormone [hPTH-(1-34)] plus alendronate	Drug: Human parathyroid hormone [hPTH-(1-34)] 37 mcg once daily by self-administered sc injection Other Names: teriparatide Drug: alendronate 70 mg/week by oral route Other Names: Fosamax

Arm

Intervention/Treatment

Experimental: PTH

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

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

37 mcg once daily by self-administered sc injection

Other Names:

teriparatide

Active Comparator: ALN

Alendronate

Drug: alendronate

70 mg/week by oral route

Other Names:

Fosamax

Experimental: PTH+ALN

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

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

37 mcg once daily by self-administered sc injection

Other Names:

teriparatide

Drug: alendronate

70 mg/week by oral route

Other Names:

Fosamax

Outcome Measures

Primary Outcome Measures

change in spine bone mineral density [study months 30 (phase A), 42 (phase B), 54 (phase C)]

Secondary Outcome Measures

change in hip bone mineral density [study months 30 (phase A), 42 (phase B), 54 (phase C)]
change in forearm bone mineral density [study months 30 (phase A), 42 (phase B), 54 (phase C)]
change in total body bone mineral [study months 30 (phase A), 42 (phase B), 54 (phase C)]
change in femoral shaft bone mineral density [study months 30 (phase A), 42 (phase B), 54 (phase C)]
change in serum PINP [study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)]
change in serum osteocalcin [study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)]
change in serum NTX [study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)]
incidence of hypercalcemia [study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)]
incidence of hypercalciuria [study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)]
incidence of symptoms [study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)]