Clinical trial NCT00000400: Alendronate and/or Parathyroid Hormone for Osteoporosis
Official title: Bone Formation-Resorption Coupling and Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Keywords: Osteoporosis
Bone formation
Bone resorption
Parathyroid hormone (PTH)
Postmenopause
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 1999-11-04
Enrollment: 176
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in spine bone mineral density
timeFrame: study months 30 (phase A), 42 (phase B), 54 (phase C)
Secondary outcomes:
measure: change in hip bone mineral density
timeFrame: study months 30 (phase A), 42 (phase B), 54 (phase C)
measure: change in forearm bone mineral density
timeFrame: study months 30 (phase A), 42 (phase B), 54 (phase C)
measure: change in total body bone mineral
timeFrame: study months 30 (phase A), 42 (phase B), 54 (phase C)
measure: change in femoral shaft bone mineral density
timeFrame: study months 30 (phase A), 42 (phase B), 54 (phase C)
measure: change in serum PINP
timeFrame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
measure: change in serum osteocalcin
timeFrame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
measure: change in serum NTX
timeFrame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
measure: incidence of hypercalcemia
timeFrame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
measure: incidence of hypercalciuria
timeFrame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
measure: incidence of symptoms
timeFrame: study months 0-30 (phase A), 30-42 (phase B), 42-54 (phase C)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Robert M. Neer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.