{"doi":"10.1210/clinem/dgaa489","title":"Effect of Teriparatide on Bone Remodeling and Density in Premenopausal Idiopathic Osteoporosis: A Phase II Trial","abstract":"CONTEXT: Premenopausal women with idiopathic osteoporosis (IOP) have abnormal skeletal microarchitecture and variable tissue-level bone formation rate (BFR). OBJECTIVES: Compare 6 months (M) of teriparatide versus placebo on areal bone mineral density (aBMD) by dual-energy x-ray absorptiometry (DXA), bone turnover markers (BTMs) and BFR at 3M by quadruple-labeled transiliac biopsy. Characterize 12M and 24M effects of teriparatide on aBMD and whether BTMs and BFR predict response. DESIGN: 6M phase 2 randomized controlled trial (RCT) followed by open extension. SETTING: Tertiary referral centers. PATIENTS: Premenopausal women with IOP. INTERVENTIONS: A total of 41 women were randomized to either teriparatide 20 mcg (n = 28) or placebo (n = 13). After 6M, those on placebo switched to teriparatide for 24M; those on teriparatide continued for 18M. MAIN OUTCOME MEASURES: 6M RCT: Between-group differences in lumbar spine (LS) aBMD (percent change from baseline), 3M BFR, and hypercalcemia. Open-label extension: Within-group change in LS aBMD over 12M and 24M. Secondary outcomes included aBMD change at other sites and relationship between BTMs, BFR, and changes in aBMD. FINDINGS: Over 6M, LS aBMD increased by 5.5% (95% CI: 3.83, 7.19) in teriparatide and 1.5% (95% CI: -0.73, 3.83) in placebo (P = 0.007). There were increases in 3M BTMs, and BFR (cancellous and endocortical BFR: between-groups P = 0.004). Over 24M, teriparatide increased LS aBMD by 13.2% (95% CI: 10.3, 16.2), total hip by 5.2% (95% CI: 3.7, 6.7) and femoral neck by 5.0% (95% CI: 3.2, 6.7; all P ≤ 0.001). Serum N-terminal propeptides of procollagen type 1 (P1NP) and 3M endocortical BFR were moderately associated with LS aBMD response. Teriparatide was well-tolerated. CONCLUSIONS: Teriparatide increased BFR and formation markers and was associated with marked aBMD improvements in most premenopausal women (82%) with IOP.","journal":"The Journal of Clinical Endocrinology & Metabolism","year":2020,"id":95483,"datarank":1.0812960005511294,"base_score":3.6109179126442243,"endowment":3.6109179126442243,"self_citation_contribution":0.5416376868966337,"citation_network_contribution":0.5396583136544957,"self_endowment_contribution":0.5416376868966337,"citer_contribution":0.5396583136544957,"corpus_percentile":null,"corpus_rank":null,"citation_count":36,"citer_count":22,"citers_with_citation_signal":15,"citers_with_endowment":15,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9545,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT01440803"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":346849,"name":"Stephanie Shiau","orcid":"0000-0003-2944-3406","position":1,"is_corresponding":false},{"id":474571,"name":"Nandini Nair","orcid":"0000-0002-7958-8753","position":2,"is_corresponding":false},{"id":85489,"name":"Robert R. Recker","orcid":"0000-0002-8774-1404","position":3,"is_corresponding":false},{"id":45181,"name":"Joan M. Lappe","orcid":"0000-0001-8274-2515","position":4,"is_corresponding":false},{"id":389089,"name":"David W. Dempster","orcid":"0000-0002-2262-4039","position":5,"is_corresponding":false},{"id":240852,"name":"Thomas L. Nickolas","orcid":"0000-0001-8870-1896","position":6,"is_corresponding":false},{"id":389090,"name":"Hua Zhou","orcid":"0000-0002-2718-4108","position":7,"is_corresponding":false},{"id":342524,"name":"Sanchita Agarwal","orcid":"0000-0003-4978-0717","position":8,"is_corresponding":false},{"id":475882,"name":"Mafo Kamanda‐Kosseh","orcid":null,"position":9,"is_corresponding":false},{"id":475883,"name":"Mariana Bucovsky","orcid":null,"position":10,"is_corresponding":false},{"id":363361,"name":"John M. Williams","orcid":"0000-0001-5578-4787","position":11,"is_corresponding":false},{"id":342525,"name":"Donald J. McMahon","orcid":"0000-0003-1506-4464","position":12,"is_corresponding":false},{"id":475884,"name":"Julie Stubby","orcid":null,"position":13,"is_corresponding":false},{"id":474572,"name":"Elizabeth Shane","orcid":"0000-0002-4696-8354","position":14,"is_corresponding":false},{"id":474570,"name":"Adi Cohen","orcid":"0000-0002-0641-5747","position":0,"is_corresponding":true}],"reference_count":60,"raw_metadata":null,"created_at":"2026-07-18T22:33:57.534608Z","pmid":"32876328","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}