Effect of teriparatide on bone mineral density in PLO patients

• Research type

  Research Study

• Full title

  Cohort study of outcomes in women with pregnancy and lactation associated osteoporosis (PLO)

• IRAS ID

  320895

• Contact name

  Richard Keen

• Contact email

  richard.keen1@nhs.net

• Sponsor organisation

  RNOH, Research and Innovation Department

• Duration of Study in the UK

  2 years, 5 months, 30 days

• Research summary

  Pregnancy and lactation associated osteoporosis (PLO) is a rare but severe form of osteoporosis, which is defined by a reduction in bone mineral density, leading to fragility fractures during the last trimester of pregnancy or lactation.
  PLO treatment are currently unclear, but teriparatide, a recombinant human parathyroid hormone 1–34 with an anabolic effect on bones and short half-life, is considered a good and safe choice for young woman with PLO.
  To date, only retrospective studies have been performed assessing teriparatide in PLO. One of these studies demonstrated that at 12 months, patients on Teriparatide (n=15) versus controls (n=8) achieve a mean bone mineral density (BMD) increase of 20% versus 6.2% (p < 0.001) at the lumbar spine and 10% versus 5.8% at the total hip (p=0.43) respectively (Lampropoulou-Adamidou et al., 2021). No prospective studies have been undertaken so far to investigate efficacy of treatment with teriparatide in PLO.
  In view of the promising preliminary results (retrospective observational studies) that have been achieved with teriparatide, I will investigate whether teriparatide improves bone health in women with PLO.
  OBJECTIVES

  2. STUDY OBJECTIVES

  2.1 PRIMARY OBJECTIVE/S

  To assess investigation and treatment options of patients with PLO at Royal National Orthopaedic Hospital NHS Trust.

  2.2 SECONDARY OBJECTIVE/S

  To identify a cohort of patients with PLO and define short term outcomes of the disease burden on physical and mental health.

  STUDY METHODOLOGY

  This is a single- centre, cohort study, where clinical care of patients with PLO will be evaluated.
  Patients will be offered treatment with teriparatide 20mcg daily given subcutaneously using a self- administered injection device and Vitamin D/Calcium supplements for 12 months. If patients choose not to have the treatment with Teriparatide, they will be advised to take Vitamin D/Calcium supplements only.
  Clinical, biochemical, radiological features of newly diagnosed PLO patients will be assessed and short-term outcomes of the disease burden on physical and mental health will be investigated.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  23/PR/0217

• Date of REC Opinion

  29 Mar 2023

• REC opinion

  Unfavourable Opinion