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Alendronate and/or Parathyroid Hormone for Osteoporosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000400
First Posted: November 4, 1999
Last Update Posted: December 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Robert M. Neer, MD, Massachusetts General Hospital
November 3, 1999
November 4, 1999
December 9, 2013
August 1999
April 2006   (Final data collection date for primary outcome measure)
change in spine bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
Not Provided
Complete list of historical versions of study NCT00000400 on ClinicalTrials.gov Archive Site
  • change in hip bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in forearm bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in total body bone mineral [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in femoral shaft bone mineral density [ Time Frame: study months 30 (phase A), 42 (phase B), 54 (phase C) ]
  • change in serum PINP [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • change in serum osteocalcin [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • change in serum NTX [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of hypercalcemia [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of hypercalciuria [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
  • incidence of symptoms [ Time Frame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C) ]
Not Provided
Not Provided
Not Provided
 
Alendronate and/or Parathyroid Hormone for Osteoporosis
Bone Formation-Resorption Coupling and Osteoporosis
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoporosis
  • 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
  • Experimental: PTH
    Human parathyroid hormone [hPTH-(1-34)]
    Intervention: Drug: Human parathyroid hormone [hPTH-(1-34)]
  • Active Comparator: ALN
    Alendronate
    Intervention: Drug: alendronate
  • Experimental: PTH+ALN
    Human parathyroid hormone [hPTH-(1-34)] plus alendronate
    Interventions:
    • Drug: Human parathyroid hormone [hPTH-(1-34)]
    • Drug: alendronate
Finkelstein JS, Wyland JJ, Leder BZ, Burnett-Bowie SM, Lee H, Jüppner 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
June 2006
April 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00000400
P50 AR44855 NIAMS-023
P50AR044855 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Robert M. Neer, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Robert M. Neer, MD Massachusetts General Hospital
Massachusetts General Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP