Alendronate and/or Parathyroid Hormone for Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert M. Neer, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00000400
First received: November 3, 1999
Last updated: December 6, 2013
Last verified: December 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bone Formation-Resorption Coupling and Osteoporosis

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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
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 Name: teriparatide
Active Comparator: ALN
Alendronate
Drug: alendronate
70 mg/week by oral route
Other Name: 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 Name: teriparatide
Drug: alendronate
70 mg/week by oral route
Other Name: Fosamax

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert M. Neer, MD, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00000400     History of Changes
Other Study ID Numbers: P50 AR44855 NIAMS-023, P50AR044855
Study First Received: November 3, 1999
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Osteoporosis
Bone formation
Bone resorption
Parathyroid hormone (PTH)
Postmenopause

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hormones
Alendronate
Teriparatide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 11, 2014