OSTEOPOROSIS Ongoing Studies of Hormones and Alternative Therapies

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OSTEOPOROSISOngoing Studies of Hormones and
Alternative Therapies

• Joan A. McGowan, Ph.D.
• National Institute of Arthritis and
  Musculoskeletal and Skin Diseases

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STUDIES USING ESTROGEN PLUS PROGESTIN2002

• Throughout the NIH DSMBs met to discuss the
  relevance and impact of the WHI results on
  ongoing monitored trials
• NIAMS was conducting two studies of estrogen
  progestin in the summer of 2002
• SELENA a trial of EP in postmenopausal women
  with Lupus (discontinued)
• Combination Low-dose EP/Alendronate (continued)

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SELENAThe Safety of Estrogens in Lupus
Erythematosus National Assessment

• The major question in this one year study was
  whether hormone therapy caused an exacerbation of
  disease symptoms.
• The safety was being evaluated because lupus
  patients are
• Subject to both accelerated bone loss and
  atherosclerosis
• It was not clear from previous research whether E
  or EP increased the incidence of lupus flares

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Rationale for Stopping SELENA

• WHI results led the SELENA DSMB to unanimously
  recommend early termination
• The lack of CVD benefit in the WHI and the
  potential for the increased risk of CHD, stroke,
  venous thromboembolic events and breast cancer
  indicate this wont be a first line chronic
  disease prevention tool in lupus patients
• Analysis of the data from completed participants
  will proceed

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COMBINATION THERAPYLOW-DOSE EPALENDRONATE

• Preliminary studies indicate that the
  bone-sparing effect of low-dose continuous HT is
  comparable to that of higher doses.
• Low-dose continuous HT (0.3mg premarin 2.5 mg
  medroxyprogesterone) regimen is attractive
  because of fewer side effects and safety MAY be
  better
• This study tests
• low-dose HT,
• ALN,
• both low-dose HRT and ALN in combination.

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COMBINATION THERAPYLOW-DOSE EPALENDRONATE

• The DSMB recommended that this study continue
  although it is not known what the risks are for a
  low dose regimen
• the study is measuring bone mineral density as
  an outcome and is really too small to assess the
  risks observed in the WHI study

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What other osteoporosis
prevention/treatment strategies do we have?
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FDA Approved Osteoporosis Treatment/Prevention

• Estrogen Progestin yes but.
• Calcitonin
• New since 1995
• Bisphosphonates
• Alendronate - Fosamax
• Risedronate - Actonel
• SERMs raloxifene Evista
• PTH pending approval - Forteo

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OTHER NIH INTERVENTION TRIALS FOR OSTEOPOROSIS
PREVENTION AND TREATMENT

• Multiple NIH institutes involved in extramural
  and intramural trials of osteoporosis prevention
  and treatment interventions
• NIA, NIAMS, NIDDK, NICHD, NINR, NHLBI, NCI, NCCAM
• For the location of trials actively recruiting
• http//clinicaltrials.gov

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NIH CONDUCTS THE TRIALS THAT ARE NOT LIKELY
TO BE DONE IN THE PRIVATE SECTOR
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WHAT TYPES OF TRIALS IN OSTEOPOROSIS DOES NIH
CONDUCT?

• Nutrition and Exercise
• Combination Therapies
• Selected Drug Trials
• head to head, off patent, inexpensive drugs
• Behavioral Interventions
• Special Populations (men, children)
• Non-pharmacologic/Physical Approaches

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You will hear more about osteoporosis research
throughout the meeting and in the last session we
will discuss some exciting new directions.