alendronate and Osteoporotic Fractures studies

alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups.

Osteoporotic Fractures: Breaks in bones resulting from low bone mass and microarchitectural deterioration characteristic of OSTEOPOROSIS.

Research Excerpts

Excerpt	Relevance	Reference
"In this randomized, controlled trial, sequential therapy with once-weekly subcutaneous injection of teriparatide for 72 weeks, followed by alendronate for 48 weeks resulted in a significantly lower incidence of morphometric vertebral fracture than monotherapy with alendronate for 120 weeks in women with osteoporosis at high risk of fracture."	9.69	Sequential therapy with once-weekly teriparatide injection followed by alendronate versus monotherapy with alendronate alone in patients at high risk of osteoporotic fracture: final results of the Japanese Osteoporosis Intervention Trial-05. ( Hagino, H; Mitomo, Y; Mori, S; Nakamura, T; Soen, S; Sone, T; Sugimoto, T; Takahashi, K; Tanaka, S, 2023)
"In this randomized, controlled trial, treatment with once-weekly subcutaneous injection of teriparatide for 72 weeks was found to be associated with a significant reduction in the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture."	9.41	A randomized, controlled trial of once-weekly teriparatide injection versus alendronate in patients at high risk of osteoporotic fracture: primary results of the Japanese Osteoporosis Intervention Trial-05. ( Hagino, H; Mori, S; Nakamura, T; Sasaki, K; Soen, S; Sone, T; Sugimoto, T; Tanaka, S, 2021)
"In patients with glucocorticoid-induced osteoporosis (GIO), teriparatide significantly increased bone mineral density (BMD) and decreased vertebral fractures compared with alendronate."	9.14	Teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: an analysis by gender and menopausal status. ( Dobnig, H; Krohn, K; Langdahl, BL; Maricic, M; Marin, F; See, K; Shane, E; Warner, MR; Zanchetta, JR, 2009)
"Alendronate has been used to prevent or treat glucocorticoid-induced osteoporosis (GIO), data regarding its efficacy are inconsistent."	8.98	Effects of alendronate for treatment of glucocorticoid-induced osteoporosis: A meta-analysis of randomized controlled trials. ( Guo, JB; Luo, ZJ; Ma, T; Qin, SQ; Wang, X; Wang, YK; Zhang, YM; Zhu, C, 2018)
"This research aims to investigate and analyze the impact of alendronate sodium (ALN) plus elcatonin (EC) in treating postoperative bone pain (BP) in patients with osteoporotic fractures (OPFs)."	8.12	Impact of Alendronate Sodium plus Elcatonin on Postoperative Bone Pain in Patients with Osteoporotic Fractures. ( Han, X; Liu, N; Shi, D; Sun, Y; Wang, B, 2022)
" We used health registers to identify predictors of new major osteoporotic fractures in patients adhering to alendronate."	7.79	Characteristics of patients who suffer major osteoporotic fractures despite adhering to alendronate treatment: a National Prescription registry study. ( Abrahamsen, B; Eastell, R; Eiken, PA; Rubin, KH, 2013)
"We report a direct comparison of receptor activator of nuclear factor kappa B ligand (RANKL) inhibition (RANK-Fc) with bisphosphonate treatment (alendronate, ALN) from infancy through early adulthood in a mouse model of osteogenesis imperfecta."	7.78	Comparable outcomes in fracture reduction and bone properties with RANKL inhibition and alendronate treatment in a mouse model of osteogenesis imperfecta. ( Bargman, R; Boskey, AL; DiCarlo, E; Pleshko, N; Posham, R; Raggio, C, 2012)
"In this randomized, controlled trial, sequential therapy with once-weekly subcutaneous injection of teriparatide for 72 weeks, followed by alendronate for 48 weeks resulted in a significantly lower incidence of morphometric vertebral fracture than monotherapy with alendronate for 120 weeks in women with osteoporosis at high risk of fracture."	5.69	Sequential therapy with once-weekly teriparatide injection followed by alendronate versus monotherapy with alendronate alone in patients at high risk of osteoporotic fracture: final results of the Japanese Osteoporosis Intervention Trial-05. ( Hagino, H; Mitomo, Y; Mori, S; Nakamura, T; Soen, S; Sone, T; Sugimoto, T; Takahashi, K; Tanaka, S, 2023)
"This study evaluated the cost effectiveness of denosumab versus alendronate for secondary prevention of osteoporotic fractures among post-menopausal women in China."	5.41	Cost Effectiveness of Denosumab for Secondary Prevention of Osteoporotic Fractures Among Postmenopausal Women in China: An Individual-Level Simulation Analysis. ( Jiang, S; Jiang, Y; Li, L; Li, M; Shi, S; Si, L, 2023)
"In this randomized, controlled trial, treatment with once-weekly subcutaneous injection of teriparatide for 72 weeks was found to be associated with a significant reduction in the incidence of morphometric vertebral fractures compared with alendronate in women with primary osteoporosis who were at high risk of fracture."	5.41	A randomized, controlled trial of once-weekly teriparatide injection versus alendronate in patients at high risk of osteoporotic fracture: primary results of the Japanese Osteoporosis Intervention Trial-05. ( Hagino, H; Mori, S; Nakamura, T; Sasaki, K; Soen, S; Sone, T; Sugimoto, T; Tanaka, S, 2021)
"In the randomized, placebo-controlled, double-blind phase 3 ACTIVE study (NCT01343004), 18 months of abaloparatide 80 μg daily (subcutaneous injection) in postmenopausal women at risk of osteoporotic fracture significantly reduced the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and significantly increased bone mineral density (BMD) versus placebo regardless of baseline risk factors."	5.30	Fracture and Bone Mineral Density Response by Baseline Risk in Patients Treated With Abaloparatide Followed by Alendronate: Results From the Phase 3 ACTIVExtend Trial. ( Dore, RK; Hattersley, G; Hu, MY; Lane, NE; Leder, BZ; Singer, AJ; Zapalowski, C, 2019)
"In patients with glucocorticoid-induced osteoporosis (GIO), teriparatide significantly increased bone mineral density (BMD) and decreased vertebral fractures compared with alendronate."	5.14	Teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: an analysis by gender and menopausal status. ( Dobnig, H; Krohn, K; Langdahl, BL; Maricic, M; Marin, F; See, K; Shane, E; Warner, MR; Zanchetta, JR, 2009)
" The pivotal phase 3 trial ACTIVE and its extension (ACTIVExtend) demonstrated the efficacy of initial treatment with ABL for 18 months followed by sequential treatment with alendronate (ALN) for an additional 24 months to reduce the risk of vertebral, nonvertebral, clinical, and major osteoporotic fractures and to increase BMD in postmenopausal women with osteoporosis."	5.05	Abaloparatide: an anabolic treatment to reduce fracture risk in postmenopausal women with osteoporosis. ( Bilezikian, JP; Bone, HG; Cosman, F; Fitzpatrick, LA; McCloskey, EV; Miller, PD; Mitlak, B, 2020)
"Alendronate has been used to prevent or treat glucocorticoid-induced osteoporosis (GIO), data regarding its efficacy are inconsistent."	4.98	Effects of alendronate for treatment of glucocorticoid-induced osteoporosis: A meta-analysis of randomized controlled trials. ( Guo, JB; Luo, ZJ; Ma, T; Qin, SQ; Wang, X; Wang, YK; Zhang, YM; Zhu, C, 2018)
" The effects of 36 months' treatment with teriparatide and alendronate in women and men with glucocorticoid-induced osteoporosis were examined in an active-comparator randomized, double-blind, controlled trial."	4.88	[Efficacy of teriparatide in treatment of glucocorticoid-induced osteoporosis]. ( Soen, S, 2012)
"Abaloparatide (ABL) significantly increases bone mineral density in men with osteoporosis similar to what was reported in postmenopausal women with osteoporosis."	4.31	Cost-Effectiveness of Sequential Abaloparatide/Alendronate in Men at High Risk of Fractures in the United States. ( Caminis, J; Hiligsmann, M; Mathew, J; Pearman, L; Reginster, JY; Silverman, SS; Singer, AJ; Wang, Y, 2023)
"To evaluate the cost-effectiveness of four anti-osteoporosis medications (denosumab, zoledronate, teriparatide, and alendronate) for postmenopausal osteoporotic women in mainland China, using a stratified treatment strategy recommended by the American Association of Clinical Endocrinologists and the American College of Endocrinology (AACE/ACE)."	4.31	Economic evaluation of four treatment strategies for postmenopausal patients with osteoporosis and a recent fracture in mainland China: a cost-effectiveness analysis. ( Li, YF; Luo, C; Qu, XL; Sheng, ZF; Tian, L; Wang, QY; Xu, LL; Yang, YY; Yue, C, 2023)
"This research aims to investigate and analyze the impact of alendronate sodium (ALN) plus elcatonin (EC) in treating postoperative bone pain (BP) in patients with osteoporotic fractures (OPFs)."	4.12	Impact of Alendronate Sodium plus Elcatonin on Postoperative Bone Pain in Patients with Osteoporotic Fractures. ( Han, X; Liu, N; Shi, D; Sun, Y; Wang, B, 2022)
" We aimed to investigate whether the risk of major osteoporotic fractures in diabetes patients differs between subjects initiated with alendronate and denosumab, respectively."	4.02	The Efficacy of Alendronate Versus Denosumab on Major Osteoporotic Fracture Risk in Elderly Patients With Diabetes Mellitus: A Danish Retrospective Cohort Study. ( Al-Mashhadi, Z; Starup-Linde, J; Vestergaard, P; Viggers, R, 2021)
"This study examined the effect of once-weekly parathyroid hormone (PTH) combined with alendronate upon osteoporotic fracture healing after long-term alendronate anti-osteoporosis therapy."	4.02	Once-weekly parathyroid hormone combined with ongoing long-term alendronate treatment promotes osteoporotic fracture healing in ovariectomized rats. ( Guan, Z; Jia, J; Leng, H; Song, C; Sun, T; Wang, H; Yuan, W; Zhang, C; Zhang, W; Zhu, J, 2021)
" Conservative treatment was conducted using a soft lumbosacral orthosis plus osteoporosis drugs, either weekly alendronate (bisphosphonate) or daily teriparatide."	3.96	Is Bone Nonunion, Vertebral Deformity, or Spinopelvic Malalignment the Best Therapeutic Target for Amelioration of Low Back Pain After Osteoporotic Vertebral Fracture? ( Hashimoto, T; Iwasaki, N; Iwata, A; Kanayama, M; Oha, F; Shimamura, Y; Takahata, M, 2020)
" Cohorts consisted of 92 355 individuals 50 years or older who were new users of denosumab (n = 4624) or alendronate (n = 87 731) from May 2010 to December 2017 after at least 1 year without an antiosteoporosis medication dispensing."	3.91	Comparison of Risk of Osteoporotic Fracture in Denosumab vs Alendronate Treatment Within 3 Years of Initiation. ( Ehrenstein, V; Heide-Jørgensen, U; Pedersen, AB; Prieto-Alhambra, D; Sørensen, HT, 2019)
"The effects of both alendronate (ALN) and Drynaria rhizome extracts (DRE) alone could promote bone healing in osteoporotic fractures but there are no reports about the combined use of ALN and DRE for promotion of bone healing of fractures in osteoporotic settings."	3.88	Combined treatment with alendronate and Drynaria rhizome extracts : Effect on fracture healing in osteoporotic rats. ( Chen, H; Chen, L; Tao, ZS; Zhou, DS; Zhou, K, 2018)
"There is high evidence for secondary prevention of fractures, including hip fracture, with alendronate treatment, but alendronate's efficacy to prevent hip fractures in the oldest-old (≥80 years old), the population with the highest fracture risk, has not been studied."	3.85	Hip fracture risk and safety with alendronate treatment in the oldest-old. ( Axelsson, KF; Johansson, H; Lorentzon, M; Lundh, D; Wallander, M, 2017)
"Using previous data from Taiwan and literature, we determined cost-effectiveness thresholds for prevention of osteoporotic fractures by alendronate with a Markov model, as well as using two other translational approaches."	3.85	Establishing and evaluating FRAX ( Chan, DC; Chang, CB; Lim, LC; Lin, KP; McCloskey, EV; Tsai, KS; Yang, RS, 2017)
" Assuming a willingness to pay (WTP) of €32,000 per quality-adjusted life years (QALYs), treatment with generic alendronate is cost effective for men and women aged 50 years or more, with 10-year probabilities for major osteoporotic fractures and hip above 8."	3.83	Cost-Effectiveness of Intervention Thresholds for the Treatment of Osteoporosis Based on FRAX(®) in Portugal. ( Borgström, F; da Silva, JA; Kanis, JA; Lourenço, Ó; Marques, A; Ortsäter, G, 2016)
"Retrospective single-center cohort study of osteoporosis patients treated with alendronate or risedronate for at least 2 years and then discontinued their bisphosphonate for a drug holiday."	3.83	Determinants of change in bone mineral density and fracture risk during bisphosphonate holiday. ( Adams-Huet, B; Maalouf, NM; Poindexter, JR; Xu, LH, 2016)
" Alendronate, risedronate, zoledronate and denosumab have been shown to prevent spine, nonspine and hip fractures; in addition, teriparatide and strontium ranelate prevent both spine and nonspine fractures, and raloxifene and ibandronate prevent spine fractures."	3.81	Efficacy, effectiveness and side effects of medications used to prevent fractures. ( Reid, IR, 2015)
"Little is known of the effect of alendronate and risedronate on osteoporotic fractures after discontinuation of therapy."	3.81	Residual effect after oral bisphosphonate treatment and healthy adherer effects--the Swedish Adherence Register Analysis (SARA). ( Garellick, G; Landfeldt, E; Ström, O, 2015)
"While alendronate inhibits atherosclerosis experimentally, its effect on lower limb ischemia risk is unknown."	3.80	Alendronate and risk of lower limb ischemic vascular events: a population-based cohort study. ( Chang, HL; Chang, HT; Chen, CK; Chen, TJ; Chen, YC; Chou, HP; Huang, YC; Lee, MH; Shih, CC, 2014)
"Under real-world conditions, there is no excess risk for ONJ in osteoporosis patients >50 years old using alendronate as compared with patients using raloxifene or calcitonin."	3.80	Incidence and risk of osteonecrosis of the jaw among the Taiwan osteoporosis population. ( Kao Yang, YH; Lin, SJ; Lin, TC; Yang, CY, 2014)
"This retrospective analysis found that the incidence of VTE in Taiwanese patients with osteoporosis was low, and the risk of VTE was similar across alendronate, raloxifene, and calcitonin recipients in patients with osteoporotic fractures who were new to osteoporosis therapy."	3.80	Incidence and risk of venous thromboembolism among Taiwan osteoporotic fracture population under osteoporosis pharmacological treatments. ( Lee, CH; Lin, SJ; Lin, TC; Yang, CY; Yang, YH, 2014)
" The population was predominantly composed of women aged 60-69 years old, who had started treatment in 2000, resident in the Southeast of Brazil, who had previously suffered osteoporotic fractures, and Alendronate sodium was the drug most commonly used at baseline."	3.79	[Public spending on drugs for the treatment of osteoporosis in post-menopause]. ( Acurcio, Fde A; Andrade, EI; Brandão, CM; Cherchiglia, ML; Ferré, F; Guerra, AA; Machado, GP, 2013)
"For alendronate, the adjusted risk of major osteoporotic fractures was significantly reduced (OR 0."	3.79	Association between refill compliance to oral bisphosphonate treatment, incident fractures, and health care costs--an analysis using national health databases. ( Abrahamsen, B; Hansen, C; Olsen, KR, 2013)
"Patients treated with alendronate and raloxifene had similar adjusted fracture rates in up to 8 years of adherent treatment, and raloxifene patients had lower breast cancer rates."	3.79	Fractures in women treated with raloxifene or alendronate: a retrospective database analysis. ( Burge, R; Chu, BC; Curkendall, S; Diakun, DR; Foster, SA; Krege, JH; Shi, N; Stock, J, 2013)
" We used health registers to identify predictors of new major osteoporotic fractures in patients adhering to alendronate."	3.79	Characteristics of patients who suffer major osteoporotic fractures despite adhering to alendronate treatment: a National Prescription registry study. ( Abrahamsen, B; Eastell, R; Eiken, PA; Rubin, KH, 2013)
"We report a direct comparison of receptor activator of nuclear factor kappa B ligand (RANKL) inhibition (RANK-Fc) with bisphosphonate treatment (alendronate, ALN) from infancy through early adulthood in a mouse model of osteogenesis imperfecta."	3.78	Comparable outcomes in fracture reduction and bone properties with RANKL inhibition and alendronate treatment in a mouse model of osteogenesis imperfecta. ( Bargman, R; Boskey, AL; DiCarlo, E; Pleshko, N; Posham, R; Raggio, C, 2012)
" Medicines dispensed at a pharmacy which are indicated for the prevention of osteoporotic hip fractures (alendronate, risedronate and strontium ranelate)."	3.77	[Incidence of hip fractures due to osteoporosis in relation to the prescription of drugs for their prevention and treatment in Galicia, Spain]. ( Charle-Crespo, MÁ; Gomes-Carvalho, CS; Guerra-García, MM; Prejigueiro-Santás, A; Puga-Sarmiento, E; Rodríguez-Fernández, JB, 2011)
"In women with postmenopausal osteoporosis, we investigated the effects of 24 months of treatment with alendronate (ALN) following 18 months of treatment with abaloparatide (ABL) or placebo (PBO)."	2.87	ACTIVExtend: 24 Months of Alendronate After 18 Months of Abaloparatide or Placebo for Postmenopausal Osteoporosis. ( Bilezikian, JP; Bone, HG; Cosman, F; Dore, RK; Fitzpatrick, LA; Hattersley, G; Hu, MY; Miller, PD; Mitlak, B; Papapoulos, S; Rizzoli, R; Saag, KG; Williams, GC, 2018)
") ibandronate versus oral alendronate, (2) a correlation exists between adherence and persistence to medication and drug efficacy, and (3) any unexpected adverse events/serious adverse events (AEs/SAEs) may occur."	2.79	The non-interventional BonViva Intravenous Versus Alendronate (VIVA) study: real-world adherence and persistence to medication, efficacy, and safety, in patients with postmenopausal osteoporosis. ( Amling, M; Felsenberg, D; Hadji, P; Hofbauer, LC; Kandenwein, JA; Kurth, A, 2014)
"In women with osteopenia or osteoporosis, 6 years of zoledronic acid reduced clinical fractures (HR, 0."	2.61	Long-Term Drug Therapy and Drug Discontinuations and Holidays for Osteoporosis Fracture Prevention: A Systematic Review. ( Brasure, M; Butler, M; Ensrud, KE; Fink, HA; Forte, ML; MacDonald, R; Nelson, VA; Olson, CM; Rosebush, CE; Schousboe, JT; Taylor, BC; Ullman, K; Wilt, TJ, 2019)
"Osteoporotic fractures are a public health problem and their incidence and subsequent economic and social costs are expected to rise in the next future."	2.52	The potential impact of new effervescent alendronate formulation on compliance and persistence in osteoporosis treatment. ( Carda, S; Cisari, C; Invernizzi, M, 2015)
"Inhibition of bone resorption is fully reversible following discontinuation."	2.49	Denosumab, a new pharmacotherapy option for postmenopausal osteoporosis. ( Josse, R; Khan, A; Ngui, D; Shapiro, M, 2013)
"Osteoporosis is becoming a global epidemic in aging societies."	1.91	Comparisons Between Different Anti-osteoporosis Medications on Postfracture Mortality: A Population-Based Study. ( Chang, YF; Hsu, YH; Hwang, JS; Li, CC; Liang, FW; Wu, CH, 2023)
"Osteoporosis is a common metabolic bone disease that benefits from many newly developed anti-osteoporosis medications (AOMs)."	1.91	Eleven years secular trend of the initiation of anti-osteoporosis medications and subsequent fractures in Taiwan: From 2008 to 2018. ( Chan, DC; Chen, HM; Fu, SH; Huang, CF; Hwang, JS; Lin, JW; Wang, CY; Wu, CH; Yang, JJ; Yang, RS; Yang, TH, 2023)
" Administration of risedronate gastric-resistant does not require fasting, and this more convenient dosing administration may explain its improved efficacy."	1.72	Fracture rates and economic outcomes in patients with osteoporosis prescribed risedronate gastro-resistant versus other oral bisphosphonates: a claims data analysis. ( Alam, A; Boolell, M; Gauthier, G; Palacios, S; Thomasius, F; Vekeman, F, 2022)
"Individuals being treated for osteoporosis should be reevaluated for fracture risk routinely, including via patient education about osteoporosis and fractures and monitoring for adverse treatment effects."	1.56	Secondary Fracture Prevention: Consensus Clinical Recommendations from a Multistakeholder Coalition. ( Adib, G; Adler, RA; Åkesson, KE; Alexander, IM; Amenta, KC; Blank, RD; Brox, WT; Carmody, EE; Chapman-Novakofski, K; Clarke, BL; Cody, KM; Conley, RB; Cooper, C; Crandall, CJ; Dirschl, DR; Eagen, TJ; Elderkin, AL; Fujita, M; Greenspan, SL; Halbout, P; Hochberg, MC; Javaid, M; Jeray, KJ; Kearns, AE; Khosla, S; Kiel, DP; King, T; Koinis, TF; Koontz, JS; Kužma, M; Lindsey, C; Lorentzon, M; Lyritis, GP; Michaud, LB; Miciano, A; Morin, SN; Mujahid, N; Napoli, N; Olenginski, TP; Puzas, JE; Rizou, S; Rosen, CJ; Saag, K; Thompson, E; Tosi, LL; Tracer, H, 2020)
"The use of gastro-resistant risedronate, a convenient dosing regimen for oral bisphosphonate therapy, seems a cost-effective strategy compared with weekly alendronate, generic risedronate, and no treatment for the treatment of postmenopausal women with osteoporosis in France."	1.51	Cost-effectiveness of gastro-resistant risedronate tablets for the treatment of postmenopausal women with osteoporosis in France. ( Hiligsmann, M; Reginster, JY, 2019)
"Alendronate was ineffective to avoid spontaneous clinical vertebral fractures."	1.51	Alendronate after denosumab discontinuation in women previously exposed to bisphosphonates was not effective in preventing the risk of spontaneous multiple vertebral fractures: two case reports. ( Aguado, P; Aubry-Rozier, B; Benavent-Núñez, D; Fernández-Fernández, E; Gonzalez-Rodriguez, E; Lamy, O; Monjo-Henry, I; Stoll, D, 2019)
"Bisphosphonates (BP) are inhibitors of bone resorption and are used to treat postmenopausal osteoporosis."	1.48	Healing of fractures in osteoporotic bones in mice treated with bisphosphonates - A transcriptome analysis. ( Hauser, M; Hofstetter, W; Keller, I; Siegrist, M, 2018)
"Resultant osteoporotic fractures are a significant contributor of economic and social burden among elderly osteoporosis patients."	1.48	Treatment patterns in patients with osteoporosis at high risk of fracture in Japan: retrospective chart review. ( Baidya, S; Barron, R; Fujiwara, S; Hamaya, E; Miyauchi, A; Nicholls, RJ; Pinto, L; Takada, J; Weston, A, 2018)
"Osteoporotic intertrochanteric fractures result in serious health problems and decrease health-related quality of life (HRQoL)."	1.43	Teriparatide Improves Fracture Healing and Early Functional Recovery in Treatment of Osteoporotic Intertrochanteric Fractures. ( Chuang, PY; Hsu, RW; Huang, KC; Huang, TW; Lee, CY; Lee, MS; Lin, SJ; Shen, WJ; Shih, HN, 2016)
" We assumed that both of the fractures were associated with the long-term use of alendronate."	1.43	Localized cortical thickening of the femoral diaphysis captured on an X-ray before alendronate therapy in two cases of atypical femoral fracture. ( Iizuka, H; Iizuka, Y; Omodaka, T; Takagishi, K; Takechi, R, 2016)
"Individual agents used to treat human osteoporosis reduce fracture risk by ∼ 50-60%."	1.40	Effects of sequential osteoporosis treatments on trabecular bone in adult rats with low bone mass. ( Amugongo, SK; Dai, W; Dave, NK; Jia, J; Jiang, L; Lane, NE; Lay, YA; Li, CS; Olivera, D; Panganiban, B; Ritchie, RO; Walsh, D; Yao, W, 2014)
" During her most recent gynecology visit, she expressed concern about unusual femoral fractures being linked to long-term use of alendronate."	1.39	Menopause practitioner perspective on the American Society of Bone and Mineral Research Task Force report on atypical femoral fracture. ( Ettinger, B; Schnatz, PF; Stuenkel, CA, 2013)
"We observed three cohorts of women aged 65 years and older who initiated once-a-week dosing of bisphosphonate therapy; (1) patients adherent to alendronate (n = 21,615), (2) patients adherent to risedronate (n = 12,215), or (3) patients filling only a single bisphosphonate prescription (n = 5,390) as a referent population."	1.39	Effectiveness of risedronate and alendronate on nonvertebral fractures: an observational study through 2 years of therapy. ( Delmas, PD; Lange, JL; Lindsay, R; Silverman, SL; Watts, NB, 2013)
"We report a case of bilateral ulna stress fractures following bilateral femoral fractures associated with long-term bisphosphonate use."	1.39	Bilateral ulna fractures associated with bisphosphonate therapy. ( Ang, BF; Howe, TS; Koh, JS; Ng, AC, 2013)
"Alendronate treatment appeared to have a similar effect on surrogate markers in postmenopausal osteoporotic Japanese women with or without RD."	1.38	Three-year experience with alendronate treatment in postmenopausal osteoporotic Japanese women with or without renal dysfunction: a retrospective study. ( Iwamoto, J; Matsumoto, H; Sato, Y; Takeda, T; Uzawa, M, 2012)
" We did not find evidence for a reversal of fracture protection with long-term use of bisphosphonates."	1.38	Incidence of fractures of the femur, including subtrochanteric, up to 8 years since initiation of oral bisphosphonate therapy: a register-based cohort study using the US MarketScan claims databases. ( Abrahamsen, B; Pazianas, M; Russell, RG; Wang, Y, 2012)
"Osteoporotic fractures are associated with premature mortality."	1.37	Osteoporosis medication and reduced mortality risk in elderly women and men. ( Bliuc, D; Center, JR; Eisman, JA; Nguyen, ND; Nguyen, TV, 2011)
" In two trials involving 1189 and 504 women, the incidence of clinical fractures, recorded as simple adverse effects, did not differ significantly between the groups."	1.37	Denosumab. Limited efficacy in fracture prevention, too many adverse effects. ( , 2011)

Research

Studies (128)

Authors

Clinical Trials (10)

Trial Overview

Trial Outcomes

Number of Participants With New Vertebral Fractures at 18 Months

Number of Participants With Non-vertebral Fractures at 18 Months

Number of Treatment-Emergent Adverse Events Associated With Hypercalcemia at 18 Months

Percent Change in Bone Mineral Density (BMD) of Femoral Neck From Baseline to Month 18

Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 18 Months

Percent Change in Bone Mineral Density (BMD) of Total Hip From Baseline to Month 18

Kaplan-Meier Estimated Event Rate of the First Incident of Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (0.78)	29.6817
2010's	100 (78.13)	24.3611
2020's	27 (21.09)	2.80

Authors	Studies
Thomasius, F	1
Palacios, S	1
Alam, A	1
Boolell, M	1
Vekeman, F	1
Gauthier, G	1
Viggers, R	1
Al-Mashhadi, Z	1
Starup-Linde, J	1
Vestergaard, P	1
Goeree, R	1
Burke, N	1
Jobin, M	1
Brown, JP	1
Lawrence, D	1
Stollenwerk, B	1
Willems, D	1
Johnson, B	1
Wang, B	2
Sun, Y	1
Shi, D	1
Han, X	1
Liu, N	1
McConnell, M	1
Shieh, A	1
Mori, S	3
Hagino, H	3
Sugimoto, T	4
Tanaka, S	5
Mitomo, Y	1
Takahashi, K	1
Sone, T	3
Nakamura, T	4
Soen, S	3
Wu, CH	2
Li, CC	1
Hsu, YH	1
Liang, FW	1
Chang, YF	1
Hwang, JS	2
Jiang, Y	1
Jiang, S	1
Li, L	1
Shi, S	1
Li, M	1
Si, L	1
Mendes, D	1
Penedones, A	1
Alves, C	1
Oliveira, T	1
Donato, A	1
Batel-Marques, F	1
Gates, M	1
Pillay, J	1
Nuspl, M	1
Wingert, A	1
Vandermeer, B	1
Hartling, L	1
Rengel, A	1
Tran, V	1
Toh, LS	1
Hiligsmann, M	3
Silverman, SS	2
Singer, AJ	2
Pearman, L	1
Mathew, J	1
Wang, Y	3
Caminis, J	1
Reginster, JY	3
Yang, TH	1
Wang, CY	1
Fu, SH	1
Chan, DC	2
Chen, HM	1
Lin, JW	1
Huang, CF	1
Yang, JJ	1
Yang, RS	2
Tian, L	1
Luo, C	1
Li, YF	1
Wang, QY	1
Qu, XL	1
Yue, C	1
Xu, LL	1
Yang, YY	1
Sheng, ZF	1
Leder, BZ	3
Zapalowski, C	1
Hu, MY	4
Hattersley, G	5
Lane, NE	2
Dore, RK	3
Koiwai, H	1
Kamimura, M	1
Takahashi, J	1
Nakamura, Y	1
Kato, H	1
Conley, RB	1
Adib, G	1
Adler, RA	1
Åkesson, KE	1
Alexander, IM	1
Amenta, KC	1
Blank, RD	1
Brox, WT	1
Carmody, EE	1
Chapman-Novakofski, K	1
Clarke, BL	1
Cody, KM	1
Cooper, C	1
Crandall, CJ	4
Dirschl, DR	1
Eagen, TJ	1
Elderkin, AL	1
Fujita, M	1
Greenspan, SL	2
Halbout, P	1
Hochberg, MC	1
Javaid, M	1
Jeray, KJ	1
Kearns, AE	1
King, T	1
Koinis, TF	1
Koontz, JS	1
Kužma, M	1
Lindsey, C	1
Lorentzon, M	2
Lyritis, GP	1
Michaud, LB	1
Miciano, A	1
Morin, SN	1
Mujahid, N	1
Napoli, N	1
Olenginski, TP	1
Puzas, JE	1
Rizou, S	1
Rosen, CJ	1
Saag, K	1
Thompson, E	1
Tosi, LL	1
Tracer, H	1
Khosla, S	1
Kiel, DP	1
Mitlak, B	4
Bockman, RS	1
Shi, L	1
Min, N	1
Wang, F	1
Xue, QY	1
Iwata, A	2
Kanayama, M	2
Oha, F	2
Shimamura, Y	1
Hashimoto, T	2
Takahata, M	1
Iwasaki, N	2
Pongchaiyakul, C	1
Nanagara, R	1
Songpatanasilp, T	1
Unnanuntana, A	2
Williams, SA	1
Fitzpatrick, LA	4
Weiss, R	1
Watts, NB	2
Baim, S	1
Rozental, TD	1
LeBoff, MS	1
Miller, PD	3
Bilezikian, JP	3
McCloskey, EV	2
Cosman, F	4
Bone, HG	2
Zhang, C	1
Zhu, J	1
Jia, J	2
Guan, Z	1
Sun, T	1
Zhang, W	1
Yuan, W	1
Wang, H	2
Leng, H	1
Song, C	1
Gou, PG	1
Zhao, ZH	1
Zhou, JM	1
Ren, LH	1
Wang, XY	1
Mu, YF	1
Wang, YG	1
Chang, F	1
Xue, Y	1
Mori, T	3
Fujii, T	2
Ganz, DA	3
Sasaki, K	1
Cromer, SJ	1
D'Silva, KM	1
Yu, EW	1
Landon, J	1
Desai, RJ	1
Kim, SC	1
Albert, SG	1
Reddy, S	1
Axelsson, KF	1
Wallander, M	1
Johansson, H	2
Lundh, D	1
Hsu, E	1
Nanes, M	1
Karlsson, L	1
Mesterton, J	1
Tepie, MF	1
Intorcia, M	1
Overbeek, J	1
Ström, O	4
Chen, L	1
Tao, ZS	1
Chen, H	1
Zhou, K	1
Zhou, DS	1
Boskey, AL	2
Spevak, L	1
Ma, Y	1
Bauer, DC	3
Black, DM	2
Schwartz, AV	2
Hirsch, C	1
Steurer, J	1
Fujiwara, S	2
Miyauchi, A	1
Hamaya, E	1
Nicholls, RJ	1
Weston, A	1
Baidya, S	1
Pinto, L	1
Barron, R	1
Takada, J	1
Hauser, M	1
Siegrist, M	1
Keller, I	1
Hofstetter, W	1
Anastasilakis, AD	1
Polyzos, SA	1
Makras, P	1
Williams, GC	2
Papapoulos, S	1
Rizzoli, R	2
Saag, KG	1
Burns, RB	1
Rosen, H	1
Berry, S	1
Smetana, GW	1
Yoshizawa, T	1
Nishino, T	1
Okubo, I	1
Yamazaki, M	1
Wang, YK	1
Zhang, YM	1
Qin, SQ	1
Wang, X	1
Ma, T	1
Guo, JB	1
Zhu, C	1
Luo, ZJ	1
Bliuc, D	2
Tran, T	1
van Geel, T	1
Adachi, JD	1
Berger, C	1
van den Bergh, J	1
Eisman, JA	3
Geusens, P	1
Goltzman, D	1
Hanley, DA	1
Josse, RG	1
Kaiser, S	1
Kovacs, CS	1
Langsetmo, L	1
Prior, JC	1
Nguyen, TV	2
Center, JR	2
Moriwaki, K	3
Fukuda, H	1
Lamy, O	1
Fernández-Fernández, E	1
Monjo-Henry, I	1
Stoll, D	1
Aubry-Rozier, B	1
Benavent-Núñez, D	1
Aguado, P	1
Gonzalez-Rodriguez, E	1
Pedersen, AB	1
Heide-Jørgensen, U	1
Sørensen, HT	1
Prieto-Alhambra, D	1
Ehrenstein, V	1
Fink, HA	1
MacDonald, R	1
Forte, ML	1
Rosebush, CE	1
Ensrud, KE	1
Schousboe, JT	2
Nelson, VA	1
Ullman, K	1
Butler, M	1
Olson, CM	1
Taylor, BC	1
Brasure, M	1
Wilt, TJ	1
Pepe, J	1
Cipriani, C	1
Cecchetti, V	1
Ferrara, C	1
Della Grotta, G	1
Danese, V	1
Colangelo, L	1
Minisola, S	1
Von Schacht, E	1
Dambacher, MA	1
Ringe, JD	3
Dukas, L	1
Foster, SA	1
Shi, N	1
Curkendall, S	1
Stock, J	1
Chu, BC	1
Burge, R	1
Diakun, DR	1
Krege, JH	1
Olsen, KR	1
Hansen, C	1
Abrahamsen, B	3
Lindsay, R	2
Lange, JL	3
Delmas, PD	1
Silverman, SL	1
Chen, CK	1
Chang, HT	1
Chou, HP	1
Lee, MH	1
Chen, YC	2
Huang, YC	1
Chen, TJ	1
Chang, HL	1
Shih, CC	1
Brandão, CM	1
Ferré, F	1
Machado, GP	1
Guerra, AA	1
Andrade, EI	1
Cherchiglia, ML	1
Acurcio, Fde A	1
Ettinger, B	1
Stuenkel, CA	1
Schnatz, PF	1
Lin, TC	3
Yang, CY	3
Yang, YH	2
Lin, SJ	4
Hadji, P	1
Felsenberg, D	1
Amling, M	1
Hofbauer, LC	1
Kandenwein, JA	1
Kurth, A	1
Drampalos, E	1
Skarpas, G	1
Barbounakis, N	1
Michos, I	1
Cairoli, E	1
Eller-Vainicher, C	1
Ulivieri, FM	1
Zhukouskaya, VV	1
Palmieri, S	1
Morelli, V	1
Beck-Peccoz, P	1
Chiodini, I	1
Kao Yang, YH	1
Lee, CH	1
Matsumoto, T	1
Hosoi, T	2
Miki, T	1
Gorai, I	2
Yoshikawa, H	2
Tanaka, Y	2
Nakano, T	1
Ito, M	1
Matsui, S	1
Yoneda, T	1
Takami, H	1
Watanabe, K	1
Osakabe, T	1
Shiraki, M	2
Fukunaga, M	2
Amugongo, SK	1
Yao, W	1
Lay, YA	1
Dai, W	1
Jiang, L	1
Walsh, D	1
Li, CS	1
Dave, NK	1
Olivera, D	1
Panganiban, B	1
Ritchie, RO	1
Abetel, G	1
Ferrari, S	1
Invernizzi, M	1
Cisari, C	1
Carda, S	1
Messori, A	1
Fadda, V	1
Maratea, D	1
Trippoli, S	1
Marinai, C	1
McNabb, B	1
Vittinghoff, E	1
Eastell, R	2
Ensrud, K	1
Barrett-Connor, E	1
Landfeldt, E	1
Garellick, G	1
Stuckey, BG	1
Sallie, R	1
Özsoy, MH	1
Aksekili, MA	1
Kızılay, O	1
Dinçel, VE	1
Aydoğan, NH	1
Ozsoy, A	1
Reid, IR	1
Schilcher, J	1
Koeppen, V	1
Aspenberg, P	1
Michaëlsson, K	1
Nieves, JW	1
Zion, M	1
Garrett, P	1
Neubort, S	1
Dempster, D	1
Koh, JH	1
Myong, JP	1
Jung, SM	1
Lee, J	1
Kwok, SK	1
Park, SH	1
Ju, JH	1
Ebina, K	1
Noguchi, T	1
Hirao, M	1
Hashimoto, J	1
Kaneshiro, S	1
Yukioka, M	1
Su, FM	1
Cheng, TT	1
Lai, HM	1
Yu, SF	1
Xu, LH	1
Adams-Huet, B	1
Poindexter, JR	1
Maalouf, NM	1
Marques, A	1
Lourenço, Ó	1
Ortsäter, G	1
Borgström, F	2
Kanis, JA	4
da Silva, JA	1
Connolly, JG	1
Gagne, JJ	1
Chang, CB	1
Lin, KP	1
Lim, LC	1
Tsai, KS	1
Huang, TW	1
Chuang, PY	1
Lee, CY	1
Huang, KC	1
Shih, HN	1
Lee, MS	1
Hsu, RW	1
Shen, WJ	1
Chen, JS	1
Chen, PM	1
Lin, CY	1
Chen, RF	1
Lee, PY	1
Iizuka, Y	1
Takechi, R	1
Iizuka, H	1
Omodaka, T	1
Takagishi, K	1
Yoshimura, M	1
Noto, S	1
Takiguchi, T	1
Davis, S	1
Martyn-St James, M	1
Sanderson, J	1
Stevens, J	1
Goka, E	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double-blind, Placebo-Controlled, Comparative Multicenter Phase 3 Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Injection for Prevention of Fracture in Ambulatory Postmenopausal Women With Severe Osteoporosis and at [NCT01343004]	Phase 3	2,463 participants (Actual)	Interventional	2011-04-30	Completed
An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003[NCT01657162]	Phase 3	1,139 participants (Actual)	Interventional	2012-11-20	Completed
Effect of Anti-osteoporotic Medications on Hepatic Steatosis and Fibrosis of Women With Postmenopausal Osteoporosis and Nonalcoholic Fatty Liver Disease[NCT05493761]	Phase 4	70 participants (Anticipated)	Interventional	2022-12-23	Recruiting
Alendronate in an Weekly Effervescent Tablet Formulation for Preservation of Bone Mass After Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass. An Observational Study (Binosto After Denosumab - The BAD Study)[NCT04338529]		92 participants (Actual)	Observational	2020-04-01	Active, not recruiting
Risedronate With High-dose Vitamin D Resolves Hyperparathyroidism and Hypovitaminosis D But Not Osteoporosis in Mexican Postmenopausal Patients[NCT05346419]		33 participants (Actual)	Interventional	2021-07-01	Completed
A Randomized, Double-Blind, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of Denosumab in Japanese Osteoporotic Subjects With Prevalent Fragility Vertebral Fracture(s)[NCT00680953]	Phase 3	1,262 participants (Actual)	Interventional	2008-05-31	Completed
STOP Vertigo: Supplementation of Vitamin D for Termination of Recurrences From Benign Paroxysmal Positional Vertigo[NCT05863949]		860 participants (Anticipated)	Interventional	2023-07-31	Not yet recruiting
Resolution of Hyperparathyroidism With High-dose Vitamin D Improves Osteoporosis in Multi-treated Postmenopausal Women[NCT05347082]		47 participants (Actual)	Interventional	2021-04-29	Completed
An Open-Label, Single-Arm, Multicenter Study to Evaluate the Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption[NCT03710889]	Phase 3	23 participants (Actual)	Interventional	2018-09-20	Completed
A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis Every 6 Months)[NCT00089791]	Phase 3	7,808 participants (Actual)	Interventional	2004-08-01	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	participants (Number)
Placebo	30
BA058 80 mcg (Abaloparatide)	4
Teriparatide	6

Intervention	Participants (Number)
Placebo	33
BA058 80 mcg (Abaloparatide)	18
Teriparatide	24

Intervention	Hypercalcemic events (Number)
Placebo	5
BA058 80 mcg (Abaloparatide)	15
Teriparatide	34

Intervention	percent change (Mean)
Placebo	-0.44
BA058 80 mcg (Abaloparatide)	2.90
Teriparatide	2.26

Intervention	percent change from baseline (Mean)
Placebo	0.48
BA058 80 mcg (Abaloparatide)	9.20
Teriparatide	9.12

Intervention	percent change (Mean)
Placebo	-0.08
BA058 80 mcg (Abaloparatide)	3.44
Teriparatide	2.81

Nonvertebral fractures were defined as clinical fractures that included: 1) those of the hip, wrist, forearm, shoulder, collar bone, upper arm, ribs, upper leg (not hip), knee, lower leg (not knee or ankle), foot, ankle, hand, pelvis (not hip), tailbone, and other; and 2) those associated with low trauma, defined as a fall from standing height or less; a fall on stairs, steps or curbs; a minimal trauma other than a fall; or moderate trauma other than a fall. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Number of Participants With ≥1 New Vertebral Fracture Since Study BA058-05-003 Baseline

Intervention	percentage of events (Number)
Abaloparatide-SC/Alendronate	2.7
Placebo/Alendronate	5.6

Vertebral fractures were determined clinically and via protocol directed radiograph evaluation. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1) up to Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Number of Participants With a Clinically Notable Coagulation Laboratory Value (Data From Study BA058-05-005 Only)

Intervention	Participants (Count of Participants)
Abaloparatide-SC/Alendronate	3
Placebo/Alendronate	25

Coagulation laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Activated Partial Thromboplastin Time (≥1.41*ULN), Prothrombin Time (≥1.21*ULN). Because the Activated Partial Thromboplastin Time was the only coagulation laboratory parameter with at least 1 participant with a notable laboratory value, this is the only parameter presented below. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Number of Participants With a Nonvertebral Fracture Since Study BA058-05-003 Baseline (Data From Studies BA058-05-005 and BA058-05-003 Combined)

Intervention	Participants (Count of Participants)
Abaloparatide-SC/Alendronate	9
Placebo/Alendronate	4

Percent Change From Study BA058-05-003 Baseline in Femoral Neck BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Intervention	Participants (Count of Participants)
Abaloparatide-SC/Alendronate	15
Placebo/Alendronate	32

Femoral neck BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Percent Change From Study BA058-05-003 Baseline in Lumbar Spine BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Intervention	percent change (Mean)
Abaloparatide-SC/Alendronate	4.5113
Placebo/Alendronate	0.4649

Lumbar spine BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Percent Change From Study BA058-05-003 Baseline in Total Hip BMD at Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Intervention	percent change (Mean)
Abaloparatide-SC/Alendronate	12.7921
Placebo/Alendronate	3.5133

Total hip BMD were measured via DXA. Complete results for Study BA058-05-003 are reported in the ClinicalTrials.gov Study Record NCT02653417. (NCT01657162)
Timeframe: Study BA058-05-003 Baseline (Day 1), Study BA058-05-005 Month 6 (Study BA058-05-003 Month 25)

Number of Participants With a Clinically Notable Hematology Laboratory Value (Data From Study BA058-05-005 Only)

Intervention	percent change (Mean)
Abaloparatide-SC/Alendronate	5.4737
Placebo/Alendronate	1.3698

Hematology laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Absolute Eosinophils (>5000 cells/mm^3), Absolute Lymphocytes (≤499 cells/mm^3), Absolute Neutrophils (≤999 cells/mm^3), % Eosinophils (>50%), % Lymphocytes (≤5%), % Neutrophils (≤10%), Hemoglobin (Low: ≤9.4 g/dL; High: change from baseline ≥2.1 g/dL), Platelets (≤99000 cells/mm^3), and White Blood Cells (Low: ≤1499 cells/mm^3; High: ≥20001 cells/mm^3). Only the hematology parameters with at least 1 participant with a notable laboratory value are presented. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Number of Participants With a Clinically Notable Serum Chemistry Laboratory Value (Data From Study BA058-05-005 Only)

Intervention	Participants (Count of Participants)
	Absolute Lymphocytes	Lymphocytes (Absolute Count or Percentage)	Absolute Neutrophils	Neutrophils (Absolute Count or Percentage)	Hemoglobin (Low)	Hemoglobin (High)	Platelets
Abaloparatide-SC/Alendronate	15	15	0	0	7	19	1
Placebo/Alendronate	11	11	2	2	2	17	0

Serum Chemistry laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: sodium (Low: ≤129; High: ≥148 milliequivalent per liter [mEq/L]), potassium (Low: ≤3.2; High: ≥5.5 mEq/L), albumin (<2.5 grams [g]/deciliter [dL]), total protein (<5 g/dL), glucose (Low: ≤54; High: >125 mg/dL [fasting] or >200 milligrams [mg]/dL [random]), creatinine (≥2.1 mg/dL), aspartate aminotransferase (AST) (≥5.1*upper limit of normal [ULN]), alanine aminotransferase (ALT) (≥5.1*ULN), alkaline phosphatase (AP) (≥3.1*ULN), total bilirubin (≥1.51*ULN [with any increase in liver function tests] ≥2.0*ULN [with normal liver function tests]), creatine kinase (≥3.1*ULN), total cholesterol (>226 mg/dL), and total calcium (Low: ≤7.4; High: ≥11.6 mg/dL). Only the serum chemistry parameters with at least 1 participant with a notable laboratory value are presented. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Number of Participants With a Clinically Notable Urine Laboratory Value (Data From Study BA058-05-005 Only)

Intervention	Participants (Count of Participants)
	Alkaline Phosphatase	Cholesterol Total	Creatine Kinase	Glucose (Fasting; High)	Glucose (Random)	Potassium (Low)	Potassium (High)	Sodium (Low)	Sodium (High)
Abaloparatide-SC/Alendronate	1	75	2	22	1	1	4	1	6
Placebo/Alendronate	0	73	1	18	2	3	3	1	2

Urine laboratory parameters that were evaluated via notable criteria (presented in parentheses) included: Glucose (2+), Protein (2+), Blood (>50 red blood cells per high-power field [rbc/hpf]). (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Data From Study BA058-05-005 Only)

Intervention	Participants (Count of Participants)
	Glucose	Protein	Blood
Abaloparatide-SC/Alendronate	4	6	77
Placebo/Alendronate	3	6	50

A TEAE is any untoward medical occurrence or undesirable event(s) experienced in a participant that begins or worsens following administration of study drug, whether or not considered related to study drug by Investigator. A serious adverse event (SAE) was an adverse event (AE) resulting in any of the following outcomes or deemed significant for any other reason, death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), congenital anomaly/birth defect, or persistent or significant disability/incapacity. Intensity for each AE was defined as mild, moderate, or severe. AEs included both SAEs and non-serious AEs. AEs whose causal relation was characterized as Possible or Probable were considered as related to study drug. AEs were coded using Medical Dictionary for Regulatory Activities (MedDRA). A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. (NCT01657162)
Timeframe: Study BA058-05-005 Baseline (Day 1) up to Study BA058-05-005 Month 24

Incidence of New or Worsening Vertebral Fractures in Osteoporotic Subjects Treated With Denosumab Compared to Placebo

Percentage of Participants With Hip Fractures in Osteoporotic Participants Treated With Denosumab Compared to Treatment With Placebo.

Intervention	Participants (Count of Participants)
	TEAEs	TEAEs Related to Study Treatment	Severe TEAEs	Serious TEAEs	TEAEs Leading to Death	TEAEs Leading to Discontinuation
Abaloparatide-SC/Alendronate	452	85	38	65	0	30
Placebo/Alendronate	466	80	40	58	2	36

Intervention	Vertebral fractures (Mean)
Denosumab	3.6
Placebo	10.3
Alendronate	7.2

The results are expressed as a percentage by Kaplan-Meier estimate. (NCT00680953)
Timeframe: Baseline to 24 Months

The Percentage of Non-vertebral Fractures

Intervention	percentage of participants (Number)
Denosumab	0.0
Placebo	0.5
Alendronate	0.0

The results are expressed as percentage by Kaplan-Meier estimate the percentage of participants with non-vertebral fractures (NCT00680953)
Timeframe: Baseline to 24 Months

Change From Baseline in Bone Formation Rate/Bone Surface (BFR/BS) in the Cancellous Envelope at Month 3

Intervention	percentage of participants (Number)
Denosumab	4.1
Placebo	4.1
Alendronate	2.7

Change in dynamic histomorphometry indices was assessed in the cancellous envelope. BFR/BS was reported as cubic millimeter/square millimeter/year (mm^3/mm^2/year). (NCT03710889)
Timeframe: Baseline (Day 1), Month 3

Change From Baseline in Mineralizing Surface/Bone Surface (MS/BS) in the Cancellous Envelope at Month 3

Intervention	mm^3/mm^2/year (Mean)
	Baseline	Change at Month 3
Abaloparatide	0.011	0.034

Change in dynamic histomorphometry indices was assessed in the cancellous envelope. (NCT03710889)
Timeframe: Baseline (Day 1), Month 3

Change in Serum Carboxy-Terminal Cross-Linking Telopeptide of Type I Collagen (s-CTX) From Baseline at Month 1 and Month 3

Intervention	percentage of MS/BS (Mean)
	Baseline	Change at Month 3
Abaloparatide	5.74	18.66

Blood samples were taken to measure efficacy-related markers of bone metabolism at Day 1, Month 1, and Month 3. (NCT03710889)
Timeframe: Baseline (Day 1), Months 1 and 3

Change in Serum Procollagen Type I N-terminal Propeptide (s-P1NP) From Baseline at Month 1 and Month 3

Intervention	ng/mL (Median)
	Baseline	Change at Month 1	Change at Month 3
Abaloparatide	0.460	0.052	0.311

Blood samples were taken to measure efficacy related markers of bone metabolism at Day 1, Month 1, and Month 3. (NCT03710889)
Timeframe: Baseline (Day 1), Months 1 and 3

Number of Participants With a Hip Fracture

Intervention	nanograms (ng)/milliliter (mL) (Median)
	Baseline	Change at Month 1	Change at Month 3
Abaloparatide	54.990	119.155	141.130

Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter. (NCT00089791)
Timeframe: 36 months

Number of Participants With New Vertebral Fractures

Intervention	Participants (Number)
Placebo	43
Denosumab 60 mg Q6M	26

A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms [or both] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture). (NCT00089791)
Timeframe: 36 months

Number of Participants With Nonvertebral Fractures

Intervention	Participants (Number)
Placebo	264
Denosumab 60 mg Q6M	86

Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary. (NCT00089791)
Timeframe: 36 months

alendronate and Osteoporotic Fractures