Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
Condition: Adult Idiopathic Generalized Osteoporosis
MeSH terms: Osteoporosis
Intervention: Teriparatide; Saline Placebo
Intervention description: Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.; Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months.
Intervention MeSH terms: Teriparatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: Female
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: osteoporosis; premenopausal; forteo; idiopathic; Idiopathic Osteoporosis in Premenopausal Women

Summary:

      Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise
      completely healthy individuals with no secondary cause of bone loss. In the course of our
      prior research with premenopausal women with IOP, the investigators have shown that women
      with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared to
      normal women. Additionally, using noninvasive high resolution imaging of the central and
      peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the
      investigators identified several features of bone quality in premenopausal women with IOP.

      There is currently no FDA-approved therapy for IOP in premenopausal women. However,
      teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in
      postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as well
      as men, premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis.
      Because IOP in premenopausal women is an orphan disease, with an estimated prevalence of
      about 113,000 in the United States, pharmaceutical companies are unlikely to support
      development of therapies for this indication. Therefore, the major objective of this protocol
      is to establish the safety and efficacy of teriparatide in premenopausal women with IOP in a
      phase 2 clinical trial. All subjects will receive teriparatide as part of the study, but a
      randomly selected group of patients (10) will receive one year of placebo injections first
      before starting their two years of treatment. The remainder of subjects (30) will receive
      active drug only for two years.

      Funding Source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women, aged 20-45, with regular menses and no historical or biochemical
             secondary cause of osteoporosis.

          -  Documented adult fractures judged to be low-trauma.

          -  Must be willing to use effective contraception throughout the period of study drug
             administration.

        Inclusion Criteria - vary slightly based on age category:

          -  Premenopausal women ages 20-35 years must have at least one major osteoporotic
             fracture (excluding fractures of fingers, toes and face) and low Bone Mineral Density
             (BMD).

          -  Premenopausal women above the age of 35 years should have a history of fracture and/or
             low BMD.

        Exclusion Criteria:

          -  History of any condition that increases the risk of osteosarcoma

          -  Early follicular phase serum

          -  Disorders of mineral metabolism

          -  Suspicion of osteomalacia

          -  Vitamin D deficiency

          -  Pregnancy or lactation within past 12 months

          -  Prolonged amenorrhea (> 6 months) during reproductive years (except pregnancy or
             lactation)

          -  Prior eating disorder

          -  Malignancy, except cured basal or squamous cell skin carcinoma

          -  Endocrinopathy: new onset untreated hyperthyroidism, hypothyroidism, Cushing's
             syndrome, prolactinoma

          -  Renal insufficiency

          -  Liver disease

          -  Intestinal disorders

          -  History/current glucocorticoids (GCs), anticonvulsants, anticoagulants, methotrexate,
             depot progesterone, Gonadotrophin-releasing hormone (GnRH) agonists

          -  Oral glucocorticoid use (subject will not be excluded if used dose equivalent to less
             than prednisone 5 mg for <3 months).

          -  Current anticoagulant use or low molecular weight

          -  Depo Provera use (subjects will not be excluded if used at age>20, >5 years ago)

          -  Drugs for osteoporosis (raloxifene, bisphosphonates, denosumab, calcitonin, TPTD).
             Subjects who discontinue these medications will be eligible 3 months after stopping
             raloxifene or calcitonin, 12 months after stopping alendronate, risedronate,
             ibandronate, or pamidronate and 18 months after stopping denosumab. Subjects with
             prior use of zoledronate may be eligible if received only one dose >4 years ago. Total
             bisphosphonate exposure must be < 1 year. Subjects who have taken TPTD in the past
             will not be eligible unless used for <3 months, > 2 years ago.