Teriparatide

Teriparatide is the 1-34 fragment of human parathyroid hormone, the biologically active region. It is an anabolic agent for bone that stimulates osteoblast activity. FDA-approved since 2002 for postmenopausal osteoporosis and glucocorticoid-induced osteoporosis. Treatment is limited to 2 years due to concerns about osteosarcoma risk in rats.

PubMed results: 2,904 · Human studies: 2,049 · Animal studies: 2,220

Ranges reflect protocols studied in published research and animal-model extrapolation. Presented for research purposes only, not a recommendation or instruction for human use.

Doses studied in published research. Information presented for research purposes only, not a recommendation for human use.

• Subcutaneous — standard range 20 mcg, Once daily. Maximum 2 years

1 hour (high confidence)

• Bone density increase (Strong human clinical data): Significant increases in bone mineral density

• Transient hypercalcemia — Moderate, Common. Clinical use of PTH(1-34) is associated with dose-related increases in serum calcium, typically transient; hypercalcemia-related symptoms have been reported in osteoporosis trial populations.
• Dizziness and orthostatic symptoms — Mild, Common. Post-dose dizziness, lightheadedness, and orthostatic hypotension have been observed, especially early after initiation of daily subcutaneous administration.
• Leg cramps and musculoskeletal pain — Mild, Common. Clinical trial programs reported muscle cramps, arthralgia, and related musculoskeletal complaints among frequent non-serious adverse events.

• Increased baseline osteosarcoma risk (Established): Rat carcinogenicity studies showed dose- and duration-dependent osteosarcoma; use is contraindicated with open epiphyses, Paget disease of bone, unexplained alkaline phosphatase elevation, prior external beam or implant radiation involving the skeleton, or prior bone malignancy.
• Pre-existing hypercalcemia (Established): As an anabolic PTH fragment that raises serum calcium, administration in the setting of hypercalcemia can worsen calcium homeostasis and related complications.

Lyophilized (powder): Refrigerated (2-8°C), Up to 24 months (or per pen/device labeling). Light sensitive: yes, store dark

Reconstituted (solution): Refrigerated (2-8°C), Multi-dose pens typically refrigerated for up to 28 days after first use per product labeling. Solvent: Bacteriostatic water

• NCT01343004 — Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausal Women (PHASE3), status: COMPLETED. Indications: Osteoporosis, Postmenopausal Osteoporosis
• NCT00062595 — Vitamin K and Bone Turnover in Postmenopausal Women (PHASE3), status: COMPLETED. Indications: Osteoporosis
• NCT01801397 — A Pilot Study to Evaluate the Effect of Forsteo (Teriparatide, 1-34-rh-PTH) in Anorexia Nervosa Patients With Low Bone Mineral Density and Increased Bone Fagility (FAN-Trial) (PHASE3), status: UNKNOWN. Indications: Low Bone Mass in Anorexia Nervosa Patients
• NCT04522622 — Treatment of Adynamic Bone Disorder With Parathyroid Hormone in Chronic Kidney Disease (PHASE4), status: RECRUITING. Indications: Adynamic Bone Disease, Chronic Kidney Diseases, Cardiac Disease, Chronic Kidney Disease-Mineral and Bone Disorder
• NCT00000400 — Alendronate and/or Parathyroid Hormone for Osteoporosis (PHASE2), status: COMPLETED. Indications: Osteoporosis
• NCT00887354 — A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture (PHASE4), status: COMPLETED. Indications: Osteoporosis
• NCT01551602 — Clinical Study of AK159 in Healthy Postmenopausal Women (PHASE1), status: COMPLETED. Indications: Osteoporosis
• NCT01796301 — An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women (PHASE3), status: COMPLETED. Indications: Postmenopausal Osteoporosis
• NCT01473602 — Second Study of the Effect of Teriparatide on Hip Fracture Healing (PHASE3), status: COMPLETED. Indications: Femur Neck Fracture
• NCT00130403 — OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women (PHASE4), status: COMPLETED. Indications: Osteoporosis, Postmenopausal
• NCT04126941 — Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism, status: UNKNOWN. Indications: Hypoparathyroidism
• NCT02472782 — Adherence to Osteoporosis Treatment and Physicians' Perception Regarding Osteoporosis Medication, status: COMPLETED. Indications: Osteoporosis, Postmenopausal, Osteoporosis, Steroid Induced
• NCT00623974 — Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia (PHASE2), status: TERMINATED. Indications: Hypocalcemia
• NCT00754442 — Suspected Deficient Activation of Vitamin D in Patients With Secondary Hyperparathyroidism (NA), status: COMPLETED. Indications: Secondary Hyperparathyroidism
• NCT00065637 — Once Weekly Parathyroid Hormone for Osteoporosis (PHASE3), status: COMPLETED. Indications: Osteopenia, Osteoporosis
• NCT03396315 — Bisphosphonates for Prevention of Post-Denosumab Bone Loss (PHASE2), status: COMPLETED. Indications: IOP, Osteoporosis
• NCT06842758 — Relationship Between Thoracic Hyperkyphosis and Fall Risk in Women with Fragility Vertebral Fractures, status: ACTIVE_NOT_RECRUITING. Indications: Osteoporosis, Hyperkyphosis, Vertebral Body Fracture
• NCT02025179 — 12 Month Extension Study of the Effect of Teriparatide on Bone in People With Chronic Spinal Cord Injury (SCI) (PHASE2), status: COMPLETED. Indications: Spinal Cord Injury, Bone Loss, Osteoporosis
• NCT00046137 — Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis (PHASE3), status: COMPLETED. Indications: Osteoporosis, Postmenopausal
• NCT03002428 — A Comparison of PF708 and Forteo in Osteoporosis Patients (PHASE3), status: COMPLETED. Indications: Osteoporosis