Trial reportThe Journal of clinical endocrinology and metabolism2016
Therapy of Hypoparathyroidism With PTH(1-84): A Prospective Six Year Investigation of Efficacy and Safety.
Trial report in The Journal of clinical endocrinology and metabolism, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
51 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Efficacy and safety of parathyroid hormone analogs therapy on hypoparathyroidism: a meta-analysis.Frontiers in endocrinology · 2026Pooled it
- Hypoparathyroidism: Musculoskeletal Manifestations Related to Parathormone Deficiency.Current rheumatology reviews · 2024Pooled it
- Hypoparathyroidism: update of guidelines from the 2022 International Task Force.Archives of endocrinology and metabolism · 2022Guideline
- Safety and Efficacy of PTH 1-34 and 1-84 Therapy in Chronic Hypoparathyroidism: A Meta-Analysis of Prospective Trials.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022Pooled it
- Parathyroid Allotransplantation: A Systematic Review.Medical sciences (Basel, Switzerland) · 2022Pooled it
- Diagnosis and treatment of hypoparathyroidism: a position statement from the Brazilian Society of Endocrinology and Metabolism.Archives of endocrinology and metabolism · 2018Guideline
- Open-label extension of a randomized trial investigating safety and efficacy of rhPTH(1-84) in hypoparathyroidism.JBMR plus · 2024Trial
- PaTH Forward: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of TransCon PTH in Adult Hypoparathyroidism.The Journal of clinical endocrinology and metabolism · 2022Trial
- Safety and Efficacy of Oral Human Parathyroid Hormone (1-34) in Hypoparathyroidism: An Open-Label Study.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2021Trial
- A Randomized Double-Blind Placebo-Controlled First-In-Human Phase 1 Trial of TransCon PTH in Healthy Adults.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2020Trial
- The Effects of Long-term Administration of rhPTH(1-84) in Hypoparathyroidism by Bone Histomorphometry.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2018Trial
- Biochemical and clinical outcomes of once-daily teriparatide in refractory chronic hypoparathyroidism: A single-center experience.Northern clinics of Istanbul · 2026Article
- Bone status in patients with chronic hypoparathyroidism: results from the Italian HypoparaNET database.Aging clinical and experimental research · 2025Article
- DimericeLife · 2025Article
- PTH Substitution Therapy for Chronic Hypoparathyroidism: PTH 1-84 and Palopegteriparatide.Current osteoporosis reports · 2025Review
- Parathyroid allotransplantation for severe post-surgical hypoparathyroidism: a Brazilian experience.3 Biotech · 2024Article
- Assessment of quality of life in patients with permanent hypoparathyroidism receiving conventional treatment.Journal of diabetes and metabolic disorders · 2023Article
- Is parathyroid allotransplantation a viable option in the treatment of permanent hypoparathyroidism? A review of the literature.Endocrine · 2023Review
- The Clinical and Skeletal Effects of Long-Term Therapy of Hypoparathyroidism With rhPTH(1-84).Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2023Article
- Long-Term Safety and Efficacy of Recombinant Human Parathyroid Hormone (1-84) in Adults With Chronic Hypoparathyroidism.Journal of the Endocrine Society · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
contextHuman recombinant (rh)PTH(1-84) was recently approved for the treatment of refractory hypoparathyroidism, based upon a short-term phase 3 clinical trial. Long-term data are needed, because no time limit was placed on the treatment period.
objectiveWe studied the effect of long-term rhPTH(1-84) treatment in hypoparathyroidism for up to 6 years.
designProspective open-label study.
settingReferral center. PATIENTS: A total of 33 subjects with hypoparathyroidism.
interventionsrhPTH(1-84) treatment was initiated at a starting dose of 100 μg every other day for 6 years. Due to the availability of new dosages during the 6-year time period of the study, the dose could be and was adjusted for most patients to a daily dosing regimen.
main outcome measuresSupplemental calcium and vitamin D requirements, serum and urinary calcium (monthly for 6 mo and then biannually), serum phosphorus, bone turnover markers, and bone mineral density (BMD) biannually.
resultsTreatment with rhPTH(1-84) progressively reduced supplemental calcium requirements over 6 years by 53% (P < .0001) and 1,25-dihydroxyvitamin D requirements by 67% (P < .0001). Sixteen subjects (48%) were able to eliminate 1,25-dihydroxyvitamin D supplementation completely. Serum calcium concentration remained stable, and urinary calcium excretion fell. Lumbar spine BMD increased (3.8 ± 1%, P = .004) as did total hip BMD (2.4 ± 1%, P = .02), whereas femoral neck BMD remained stable and the distal one third radius decreased (-4.4 ±1%, P < .0001). Bone turnover markers increased significantly, reaching a 3-fold peak above baseline values at 1 year and subsequently declining but remaining higher than pretreatment values. Hypercalcemia was uncommon (12 episodes over 6 y; 2.5% of all values).
conclusionsLong-term, continuous therapy of hypoparathyroidism for 6 years with rhPTH(1-84) is associated with reductions in supplemental calcium and calcitriol requirements, stable serum calcium concentration, and reduced urinary calcium excretion. The safety profile remains good. These data represent the longest experience with the therapeutic use of PTH for any condition and demonstrate its long-term efficacy and safety in hypoparathyroidism.
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