Alendronate and/or Parathyroid Hormone for Osteoporosis

Osteoporosis Clinical Trial

Official title:

Bone Formation-Resorption Coupling and Osteoporosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000400
• Other study ID #: P50 AR44855 NIAMS-023
• Secondary ID: P50AR044855
• Status: Completed
• Phase: Phase 2
• First received: November 3, 1999
• Last updated: December 6, 2013
• Start date: August 1999
• Est. completion date: June 2006

Study information

• Verified date: December 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Human parathyroid hormone [hPTH-(1-34)]
37 mcg once daily by self-administered sc injection
• alendronate
70 mg/week by oral route

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in spine bone mineral density		study months 30 (phase A), 42 (phase B), 54 (phase C)	No
Secondary	change in hip bone mineral density		study months 30 (phase A), 42 (phase B), 54 (phase C)	No
Secondary	change in forearm bone mineral density		study months 30 (phase A), 42 (phase B), 54 (phase C)	No
Secondary	change in total body bone mineral		study months 30 (phase A), 42 (phase B), 54 (phase C)	No
Secondary	change in femoral shaft bone mineral density		study months 30 (phase A), 42 (phase B), 54 (phase C)	No
Secondary	change in serum PINP		study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)	No
Secondary	change in serum osteocalcin		study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)	No
Secondary	change in serum NTX		study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)	No
Secondary	incidence of hypercalcemia		study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)	Yes
Secondary	incidence of hypercalciuria		study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)	Yes
Secondary	incidence of symptoms		study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)	Yes

External Links

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