pamidronate and Fractures, Bone studies

Research Excerpts

Excerpt	Relevance	Reference
"Intravenous pamidronate is widely used to treat children with osteogenesis imperfecta (OI)."	9.22	Evaluation of a Modified Pamidronate Protocol for the Treatment of Osteogenesis Imperfecta. ( Andrade, MC; Carvalhaes, JT; Glorieux, FH; Lazaretti-Castro, M; Palomo, T; Peters, BS; Rauch, F; Reis, FA, 2016)
"Pamidronate (PAM) infusion is the standard treatment in children with osteogenesis imperfecta (OI)."	9.16	Safety and efficacy of a 1-year treatment with zoledronic acid compared with pamidronate in children with osteogenesis imperfecta. ( Barros, ER; de Oliveira, TP; Lazaretti-Castro, M; Saraiva, GL, 2012)
"Zoledronic acid is at least as effective as pamidronate as treatment for paediatric osteoporosis, and has a similar safety profile."	9.14	Safety and efficacy of intravenous zoledronic acid in paediatric osteoporosis. ( Brown, JJ; Zacharin, MR, 2009)
"Cyclic intravenous pamidronate treatment is widely used for symptomatic therapy of osteogenesis imperfecta (OI)."	9.13	Cyclic pamidronate therapy in children with osteogenesis imperfecta: results of treatment and follow-up after discontinuation. ( Alikasifoglu, A; Andiran, N; Gonc, N; Kandemir, N; Ozon, A; Yordam, N, 2008)
" zoledronic acid with pamidronate treatment in patients with bone metastases from breast cancer or multiple myeloma."	9.12	Zoledronic acid and survival in breast cancer patients with bone metastases and elevated markers of osteoclast activity. ( Coleman, RE; Cook, RJ; Lipton, A; Major, P; Smith, MR, 2007)
"The aim of this study was to test the efficacy of low doses of pamidronate in increasing bone mineral density (BMD) in non-ambulatory children and adolescents with cerebral palsy (CP)."	9.12	Low doses of pamidronate to treat osteopenia in children with severe cerebral palsy: a pilot study. ( Bruzoni, M; Coughlin, S; Heldt, K; Kreikemeier, R; Lerner, G; Plotkin, H, 2006)
"Cyclical iv pamidronate is a widely used symptomatic therapy of osteogenesis imperfecta (OI)."	9.12	Pamidronate in children and adolescents with osteogenesis imperfecta: effect of treatment discontinuation. ( Glorieux, FH; Land, C; Munns, C; Rauch, F, 2006)
"Cyclical intravenous treatment with pamidronate is of clinical benefit in children with moderate to severe osteogenesis imperfecta (OI) types I, III and IV, but there is no information on the effects of this treatment on the newly described OI type VI."	9.12	Osteogenesis imperfecta type VI in childhood and adolescence: effects of cyclical intravenous pamidronate treatment. ( Glorieux, FH; Land, C; Rauch, F; Travers, R, 2007)
"Nine infants and young children with osteogenesis imperfecta (age range 1-35 months) were treated with intravenous pamidronate."	9.11	Intravenous pamidronate treatment of children under 36 months of age with osteogenesis imperfecta. ( DiMeglio, LA; Ford, L; McClintock, C; Peacock, M, 2004)
"Treatment with zoledronic acid (Zol) was compared with a dose of 90 mg of pamidronate (Pam) in breast carcinoma (BC) patients with at least 1 osteolytic lesion based on data from a Phase III, randomized trial."	9.11	Zoledronic acid is superior to pamidronate for the treatment of bone metastases in breast carcinoma patients with at least one osteolytic lesion. ( Chen, BL; Coleman, RE; Dugan, W; Eisenberg, PD; Gordon, DH; Kaminski, M; Major, P; Provencher, L; Rosen, LS; Seaman, J; Simeone, J, 2004)
"To evaluate the efficacy of pamidronate in protecting against fractures, increasing bone mineral density (BMD), and decreasing bone remodeling marker levels in children with osteogenesis imperFecta."	9.10	Effect of cyclical intravenous pamidronate therapy in children with osteogenesis imperfecta. Open-label study in seven patients. ( Giraud, F; Meunier, PJ, 2002)
"Thirteen patients with McCune-Albright syndrome (MAS) and bone fibrous dysplasia (BFD) have been treated for 2-6 years with pamidronate, an aminobisphosphonate which inhibits osteoclastic function."	9.10	Pamidronate treatment in bone fibrous dysplasia in children and adolescents with McCune-Albright syndrome. ( Altare, F; Andreo, M; de Sanctis, C; Lala, R; Masi, G; Matarazzo, P, 2002)
"A prospective open study was performed to determine the efficacy and safety of pamidronate in improving bone mineralisation and reducing fracture incidence in osteogenesis imperfecta (OI)."	9.09	Cyclic pamidronate infusion improves bone mineralisation and reduces fracture incidence in osteogenesis imperfecta. ( Lee, YS; Lim, LA; Loke, KY; Low, SL, 2001)
"In an uncontrolled observational study involving 30 children who were 3 to 16 years old and had severe osteogenesis imperfecta, we administered pamidronate intravenously (mean [+/-SD] dose, 6."	9.08	Cyclic administration of pamidronate in children with severe osteogenesis imperfecta. ( Bishop, NJ; Chabot, G; Glorieux, FH; Lanoue, G; Plotkin, H; Travers, R, 1998)
"Women with stage IV breast cancer who were receiving cytotoxic chemotherapy and had at least one lytic bone lesion were given either placebo or pamidronate (90 mg) as a two-hour intravenous infusion monthly for 12 cycles."	9.08	Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. Protocol 19 Aredia Breast Cancer Study Group. ( Blayney, D; Hortobagyi, GN; Knight, RD; Lipton, A; Porter, L; Seaman, J; Simeone, JF; Sinoff, C; Theriault, RL; Wheeler, H, 1996)
"Patients with stage III multiple myeloma and at least one lytic lesion received either placebo or pamidronate (90 mg) as a four-hour intravenous infusion given every four weeks for nine cycles in addition to antimyeloma therapy."	9.08	Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group. ( Ballester, O; Bell, R; Berenson, JR; Blacklock, HA; Bordoni, R; Dimopoulos, MA; George, S; Heffernan, M; Keller, A; Knight, RD; Kovacs, MJ; Lichtenstein, A; Lipton, A; Porter, L; Reitsma, DJ; Seaman, J; Simeone, J, 1996)
"Pamidronate treatment in children with all types of OI increased LS BMD, decreased fracture rate, and improved vertebral compression fractures."	7.83	Decreased fracture rate, pharmacogenetics and BMD response in 79 Swedish children with osteogenesis imperfecta types I, III and IV treated with Pamidronate. ( Åström, E; Grigelioniene, G; Kindmark, A; Lindahl, K; Ljunggren, Ö; Malmgren, B; Rubin, CJ; Söderhäll, S, 2016)
"The six patients, who had bone fractures either in utero or in their 1st month of life, were treated with cyclic pamidronate from a mean age of 2."	7.80	Cyclic pamidronate infusion for neonatal-onset osteogenesis imperfecta. ( Chien, CC; Chien, YH; Hwu, WL; Lee, CT; Lee, NC; Lin, CH; Peng, SF; Tsai, WY; Tung, YC, 2014)
"To assess the beneficial effect of intravenous pamidronate treatment in children with osteogenesis imperfecta (OI)."	7.80	Effect of intravenous pamidronate treatment in children with osteogenesis imperfecta. ( Atta, I; Ibrahim, M; Iqbal, F; Khan, YN; Lone, SW; Raza, J, 2014)
"Evaluate clinical outcome of early cyclic intravenous pamidronate treatment in children with moderate-to-severe osteogenesis imperfecta (OI), commenced before three years of age."	7.79	Intravenous pamidronate treatment in children with moderate-to-severe osteogenesis imperfecta started under three years of age. ( Alcausin, MB; Ault, J; Bridge, C; Briody, J; Engelbert, RH; McQuade, M; Munns, CF; Pacey, V; Sillence, DO, 2013)
"The aim of this study was to assess the rate of fracture before and after a 1-year course of intravenous pamidronate in children with spastic quadriplegic cerebral palsy (CP) who had previously experienced fractures."	7.76	Decreased fracture incidence after 1 year of pamidronate treatment in children with spastic quadriplegic cerebral palsy. ( Bachrach, SJ; Harcke, HT; Hossain, J; Kecskemethy, HH, 2010)
"Cyclical intravenous treatment with pamidronate is widely used to treat osteogenesis imperfecta (OI) types I, III, and IV, which are due to dominant mutations affecting collagen type I alpha chains."	7.75	Intravenous pamidronate in osteogenesis imperfecta type VII. ( Cheung, MS; Glorieux, FH; Rauch, F, 2009)
"To study the efficacy of pamidronate in children with osteogenesis imperfecta (OI)."	7.73	Benefits of pamidronate in children with osteogenesis imperfecta: an open prospective study. ( Arabi, A; Bensman, A; Filipe, G; Forin, V; Guigonis, V; Roux, C, 2005)
"The aim of this study was to evaluate the efficacy of pamidronate in the management of osteogenesis imperfecta patients."	7.73	Surgery versus surgery plus pamidronate in the management of osteogenesis imperfecta patients: a comparative study. ( Basha, NE; el-Sobky, MA; Hanna, AA; Said, MH; Tarraf, YN, 2006)
"To examine the response to single-day intravenous pamidronate in a heterogeneous population with symptomatic osteoporosis."	7.72	Treatment of symptomatic pediatric osteoporosis with cyclic single-day intravenous pamidronate infusions. ( Steelman, J; Zeitler, P, 2003)
"Pamidronate seems to be useful in the treatment of patients with osteogenesis imperfecta."	7.71	Efficacy of low dose schedule pamidronate infusion in children with osteogenesis imperfecta. ( Escolá, J; González, E; Pavía, C; Ros, J; Valls, C; Villaronga, M, 2001)
"An open trial of pamidronate treatment was undertaken in 5 children and 4 young adults with polyostotic fibrous dysplasia associated with McCune Albright syndrome to assess clinical response, bone turnover, and cardiovascular status over a 2-year period."	7.70	Intravenous pamidronate treatment of polyostotic fibrous dysplasia associated with the McCune Albright syndrome. ( O'Sullivan, M; Zacharin, M, 2000)
"Pamidronate treatment stimulated the onset of recovery phase reducing fracture rate and permanent disabilities without evidence of side-effects."	6.78	Pamidronate treatment stimulates the onset of recovery phase reducing fracture rate and skeletal deformities in patients with idiopathic juvenile osteoporosis: comparison with untreated patients. ( Baroncelli, GI; Bertelloni, S; Erba, P; Giuca, MR; Vierucci, F; Zampollo, E, 2013)
"Pamidronate was well tolerated in the majority of the patients both during the first six infusions and during the whole study period."	6.70	The role of disodium pamidronate in the management of bone pain due to malignancy. ( Boffi, R; Brunelli, C; Cazzaniga, M; De Conno, F; Groff, L; Panzeri, C; Ripamonti, C; Zecca, E, 2001)
"Pamidronate treatment also did not have any influence on patient survival or on the frequency of hypercalcaemia."	6.69	Failure of oral pamidronate to reduce skeletal morbidity in multiple myeloma: a double-blind placebo-controlled trial. Danish-Swedish co-operative study group. ( Abildgaard, N; Brincker, H; Ford, J; Gimsing, P; Hedenus, M; Kandra, A; Turesson, I; Westin, J, 1998)
"Pamidronate treatment in severely affected OI patients under 3 yr of age is safe, increases BMD, and decreases fracture rate."	6.69	Pamidronate treatment of severe osteogenesis imperfecta in children under 3 years of age. ( Bishop, NJ; Glorieux, FH; Montpetit, K; Plotkin, H; Rauch, F; Ruck-Gibis, J; Travers, R, 2000)
"Treatment with pamidronate is beneficial for the patient, family and society, increases mobility and bone density, improves quality of life and reduces family dependence in children with OI."	5.46	Therapy with pamidronate in children with osteogenesis imperfecta. ( Brad, GF; Mang, N; Marginean, O; Mozos, I; Tamasanu, RC, 2017)
"Pamidronate was administered in three-day cycles."	5.42	Beneficial effects of intravenous pamidronate treatment in children with osteogenesis imperfecta under 24 months of age. ( Ayoob, R; Bowden, SA; Ingraham, S; Kusumi, K; Mahan, JD, 2015)
" However, clinical efficacy and optimal dosing in non-OI patients has not been established."	5.37	Treatment of symptomatic osteoporosis in children: a comparison of two pamidronate dosage regimens. ( Huang, C; Martinez-Soto, T; Pacaud, D; Stephure, D; Trussell, R, 2011)
"Intravenous pamidronate is widely used to treat children with osteogenesis imperfecta (OI)."	5.22	Evaluation of a Modified Pamidronate Protocol for the Treatment of Osteogenesis Imperfecta. ( Andrade, MC; Carvalhaes, JT; Glorieux, FH; Lazaretti-Castro, M; Palomo, T; Peters, BS; Rauch, F; Reis, FA, 2016)
"Pamidronate (PAM) infusion is the standard treatment in children with osteogenesis imperfecta (OI)."	5.16	Safety and efficacy of a 1-year treatment with zoledronic acid compared with pamidronate in children with osteogenesis imperfecta. ( Barros, ER; de Oliveira, TP; Lazaretti-Castro, M; Saraiva, GL, 2012)
"Zoledronic acid is at least as effective as pamidronate as treatment for paediatric osteoporosis, and has a similar safety profile."	5.14	Safety and efficacy of intravenous zoledronic acid in paediatric osteoporosis. ( Brown, JJ; Zacharin, MR, 2009)
"Cyclic intravenous pamidronate treatment is widely used for symptomatic therapy of osteogenesis imperfecta (OI)."	5.13	Cyclic pamidronate therapy in children with osteogenesis imperfecta: results of treatment and follow-up after discontinuation. ( Alikasifoglu, A; Andiran, N; Gonc, N; Kandemir, N; Ozon, A; Yordam, N, 2008)
"The aim of this study was to test the efficacy of low doses of pamidronate in increasing bone mineral density (BMD) in non-ambulatory children and adolescents with cerebral palsy (CP)."	5.12	Low doses of pamidronate to treat osteopenia in children with severe cerebral palsy: a pilot study. ( Bruzoni, M; Coughlin, S; Heldt, K; Kreikemeier, R; Lerner, G; Plotkin, H, 2006)
"Cyclical intravenous treatment with pamidronate is of clinical benefit in children with moderate to severe osteogenesis imperfecta (OI) types I, III and IV, but there is no information on the effects of this treatment on the newly described OI type VI."	5.12	Osteogenesis imperfecta type VI in childhood and adolescence: effects of cyclical intravenous pamidronate treatment. ( Glorieux, FH; Land, C; Rauch, F; Travers, R, 2007)
"Cyclical iv pamidronate is a widely used symptomatic therapy of osteogenesis imperfecta (OI)."	5.12	Pamidronate in children and adolescents with osteogenesis imperfecta: effect of treatment discontinuation. ( Glorieux, FH; Land, C; Munns, C; Rauch, F, 2006)
" zoledronic acid with pamidronate treatment in patients with bone metastases from breast cancer or multiple myeloma."	5.12	Zoledronic acid and survival in breast cancer patients with bone metastases and elevated markers of osteoclast activity. ( Coleman, RE; Cook, RJ; Lipton, A; Major, P; Smith, MR, 2007)
"Nine infants and young children with osteogenesis imperfecta (age range 1-35 months) were treated with intravenous pamidronate."	5.11	Intravenous pamidronate treatment of children under 36 months of age with osteogenesis imperfecta. ( DiMeglio, LA; Ford, L; McClintock, C; Peacock, M, 2004)
"Treatment with zoledronic acid (Zol) was compared with a dose of 90 mg of pamidronate (Pam) in breast carcinoma (BC) patients with at least 1 osteolytic lesion based on data from a Phase III, randomized trial."	5.11	Zoledronic acid is superior to pamidronate for the treatment of bone metastases in breast carcinoma patients with at least one osteolytic lesion. ( Chen, BL; Coleman, RE; Dugan, W; Eisenberg, PD; Gordon, DH; Kaminski, M; Major, P; Provencher, L; Rosen, LS; Seaman, J; Simeone, J, 2004)
"Thirteen patients with McCune-Albright syndrome (MAS) and bone fibrous dysplasia (BFD) have been treated for 2-6 years with pamidronate, an aminobisphosphonate which inhibits osteoclastic function."	5.10	Pamidronate treatment in bone fibrous dysplasia in children and adolescents with McCune-Albright syndrome. ( Altare, F; Andreo, M; de Sanctis, C; Lala, R; Masi, G; Matarazzo, P, 2002)
"To evaluate the efficacy of pamidronate in protecting against fractures, increasing bone mineral density (BMD), and decreasing bone remodeling marker levels in children with osteogenesis imperFecta."	5.10	Effect of cyclical intravenous pamidronate therapy in children with osteogenesis imperfecta. Open-label study in seven patients. ( Giraud, F; Meunier, PJ, 2002)
"A prospective open study was performed to determine the efficacy and safety of pamidronate in improving bone mineralisation and reducing fracture incidence in osteogenesis imperfecta (OI)."	5.09	Cyclic pamidronate infusion improves bone mineralisation and reduces fracture incidence in osteogenesis imperfecta. ( Lee, YS; Lim, LA; Loke, KY; Low, SL, 2001)
"Women with stage IV breast cancer who were receiving cytotoxic chemotherapy and had at least one lytic bone lesion were given either placebo or pamidronate (90 mg) as a two-hour intravenous infusion monthly for 12 cycles."	5.08	Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases. Protocol 19 Aredia Breast Cancer Study Group. ( Blayney, D; Hortobagyi, GN; Knight, RD; Lipton, A; Porter, L; Seaman, J; Simeone, JF; Sinoff, C; Theriault, RL; Wheeler, H, 1996)
"In an uncontrolled observational study involving 30 children who were 3 to 16 years old and had severe osteogenesis imperfecta, we administered pamidronate intravenously (mean [+/-SD] dose, 6."	5.08	Cyclic administration of pamidronate in children with severe osteogenesis imperfecta. ( Bishop, NJ; Chabot, G; Glorieux, FH; Lanoue, G; Plotkin, H; Travers, R, 1998)
"Patients with stage III multiple myeloma and at least one lytic lesion received either placebo or pamidronate (90 mg) as a four-hour intravenous infusion given every four weeks for nine cycles in addition to antimyeloma therapy."	5.08	Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group. ( Ballester, O; Bell, R; Berenson, JR; Blacklock, HA; Bordoni, R; Dimopoulos, MA; George, S; Heffernan, M; Keller, A; Knight, RD; Kovacs, MJ; Lichtenstein, A; Lipton, A; Porter, L; Reitsma, DJ; Seaman, J; Simeone, J, 1996)
" The parent compound, etidronate, was first used in multicentered trials for the treatment of primary osteoporosis and showed some success in increasing bone density and perhaps controlling fracture rates."	4.79	Bisphosphonate therapy. ( Licata, AA, 1997)
"Pamidronate treatment in children with all types of OI increased LS BMD, decreased fracture rate, and improved vertebral compression fractures."	3.83	Decreased fracture rate, pharmacogenetics and BMD response in 79 Swedish children with osteogenesis imperfecta types I, III and IV treated with Pamidronate. ( Åström, E; Grigelioniene, G; Kindmark, A; Lindahl, K; Ljunggren, Ö; Malmgren, B; Rubin, CJ; Söderhäll, S, 2016)
"The six patients, who had bone fractures either in utero or in their 1st month of life, were treated with cyclic pamidronate from a mean age of 2."	3.80	Cyclic pamidronate infusion for neonatal-onset osteogenesis imperfecta. ( Chien, CC; Chien, YH; Hwu, WL; Lee, CT; Lee, NC; Lin, CH; Peng, SF; Tsai, WY; Tung, YC, 2014)
"To assess the beneficial effect of intravenous pamidronate treatment in children with osteogenesis imperfecta (OI)."	3.80	Effect of intravenous pamidronate treatment in children with osteogenesis imperfecta. ( Atta, I; Ibrahim, M; Iqbal, F; Khan, YN; Lone, SW; Raza, J, 2014)
"Evaluate clinical outcome of early cyclic intravenous pamidronate treatment in children with moderate-to-severe osteogenesis imperfecta (OI), commenced before three years of age."	3.79	Intravenous pamidronate treatment in children with moderate-to-severe osteogenesis imperfecta started under three years of age. ( Alcausin, MB; Ault, J; Bridge, C; Briody, J; Engelbert, RH; McQuade, M; Munns, CF; Pacey, V; Sillence, DO, 2013)
"The aim of this study was to assess the rate of fracture before and after a 1-year course of intravenous pamidronate in children with spastic quadriplegic cerebral palsy (CP) who had previously experienced fractures."	3.76	Decreased fracture incidence after 1 year of pamidronate treatment in children with spastic quadriplegic cerebral palsy. ( Bachrach, SJ; Harcke, HT; Hossain, J; Kecskemethy, HH, 2010)
"Cyclical intravenous treatment with pamidronate is widely used to treat osteogenesis imperfecta (OI) types I, III, and IV, which are due to dominant mutations affecting collagen type I alpha chains."	3.75	Intravenous pamidronate in osteogenesis imperfecta type VII. ( Cheung, MS; Glorieux, FH; Rauch, F, 2009)
"Recent studies reported beneficial effect of cyclical intravenous administration of pamidronate in children and adolescents with osteogenesis imperfecta (OI)."	3.74	Alendronate treatment in children with osteogenesis imperfecta. ( Akcay, T; Bereket, A; Guran, T; Turan, S, 2008)
"To determine the effect of intravenous pamidronate on the bone mineral density of children with osteogenesis imperfecta and spastic quadriplegic cerebral palsy."	3.73	Bone densitometry in pediatric patients treated with pamidronate. ( Bachrach, SJ; Grissom, LE; Harcke, HT; Kecskemethy, HH; McKay, C, 2005)
"To study the efficacy of pamidronate in children with osteogenesis imperfecta (OI)."	3.73	Benefits of pamidronate in children with osteogenesis imperfecta: an open prospective study. ( Arabi, A; Bensman, A; Filipe, G; Forin, V; Guigonis, V; Roux, C, 2005)
"The aim of this study was to evaluate the efficacy of pamidronate in the management of osteogenesis imperfecta patients."	3.73	Surgery versus surgery plus pamidronate in the management of osteogenesis imperfecta patients: a comparative study. ( Basha, NE; el-Sobky, MA; Hanna, AA; Said, MH; Tarraf, YN, 2006)
"In recent years, bisphosphonates, primarily intravenous (iv) pamidronate, have become very widely used in children with severe osteogenesis imperfecta (OI)."	3.73	Low doses of pamidronate for the treatment of osteopenia in non-ambulatory children. ( Henderson, R, 2006)
"To examine the response to single-day intravenous pamidronate in a heterogeneous population with symptomatic osteoporosis."	3.72	Treatment of symptomatic pediatric osteoporosis with cyclic single-day intravenous pamidronate infusions. ( Steelman, J; Zeitler, P, 2003)
"Pamidronate seems to be useful in the treatment of patients with osteogenesis imperfecta."	3.71	Efficacy of low dose schedule pamidronate infusion in children with osteogenesis imperfecta. ( Escolá, J; González, E; Pavía, C; Ros, J; Valls, C; Villaronga, M, 2001)
"An open trial of pamidronate treatment was undertaken in 5 children and 4 young adults with polyostotic fibrous dysplasia associated with McCune Albright syndrome to assess clinical response, bone turnover, and cardiovascular status over a 2-year period."	3.70	Intravenous pamidronate treatment of polyostotic fibrous dysplasia associated with the McCune Albright syndrome. ( O'Sullivan, M; Zacharin, M, 2000)
"Three children (ages 9 to 11 years) with osteoporosis pseudoglioma syndrome who had multiple vertebral collapse were treated over a 2-year period with intermittent intravenous bisphosphonate infusions (pamidronate in 2, clodronate in 1)."	3.70	Osteoporosis pseudoglioma syndrome: treatment of spinal osteoporosis with intravenous bisphosphonates. ( Cundy, T; Zacharin, M, 2000)
" One of the earliest agents to be investigated, etidronate, is effective in the management of malignant hypercalcemia and, when used orally and intermittently, results in reduced bone loss in osteoporosis."	3.69	Role of bisphosphonates in prevention and treatment of bone metastases from breast cancer. ( Ashley, S; Hanson, J; Kanis, JA; McCloskey, E; Paterson, AH; Powles, TJ, 1995)
"Osteoporosis is characterized by low bone mass and micro-architectural deterioration of bone tissue leading to increased bone fragility."	3.01	Treatment for osteoporosis in people with beta-thalassaemia. ( Bhardwaj, A; Sinha, NK; Swe, KMM, 2023)
"Osteoporosis is a disorder of bone mineralisation occurring in about one third of adults with cystic fibrosis."	3.01	Bisphosphonates for osteoporosis in people with cystic fibrosis. ( Chang, AB; Conwell, LS; Jeffery, TC, 2023)
"Pamidronate treatment stimulated the onset of recovery phase reducing fracture rate and permanent disabilities without evidence of side-effects."	2.78	Pamidronate treatment stimulates the onset of recovery phase reducing fracture rate and skeletal deformities in patients with idiopathic juvenile osteoporosis: comparison with untreated patients. ( Baroncelli, GI; Bertelloni, S; Erba, P; Giuca, MR; Vierucci, F; Zampollo, E, 2013)
"Pamidronate-treated type III/IV and oral bisphosphonate-treated type I patients showed significant increases in total-hip BMD (0."	2.75	Bone mineral density and fracture rate in response to intravenous and oral bisphosphonates in adult osteogenesis imperfecta. ( Gillen, C; Nunes, M; Shapiro, JR; Thompson, CB; Wu, Y, 2010)
"Pamidronate was well tolerated in the majority of the patients both during the first six infusions and during the whole study period."	2.70	The role of disodium pamidronate in the management of bone pain due to malignancy. ( Boffi, R; Brunelli, C; Cazzaniga, M; De Conno, F; Groff, L; Panzeri, C; Ripamonti, C; Zecca, E, 2001)
"Pamidronate treatment also did not have any influence on patient survival or on the frequency of hypercalcaemia."	2.69	Failure of oral pamidronate to reduce skeletal morbidity in multiple myeloma: a double-blind placebo-controlled trial. Danish-Swedish co-operative study group. ( Abildgaard, N; Brincker, H; Ford, J; Gimsing, P; Hedenus, M; Kandra, A; Turesson, I; Westin, J, 1998)
"Pamidronate treatment in severely affected OI patients under 3 yr of age is safe, increases BMD, and decreases fracture rate."	2.69	Pamidronate treatment of severe osteogenesis imperfecta in children under 3 years of age. ( Bishop, NJ; Glorieux, FH; Montpetit, K; Plotkin, H; Rauch, F; Ruck-Gibis, J; Travers, R, 2000)
"Fibrous dysplasia of bone is a genetic, non-inheritable disease, characterized by bone pain, bone deformities and fracture, involving one or several bones."	2.44	Fibrous dysplasia of bone and McCune-Albright syndrome. ( Chapurlat, RD; Orcel, P, 2008)
"Pamidronate was well tolerated."	1.46	Lower incidence of fracture after IV bisphosphonates in girls with Rett syndrome and severe bone fragility. ( Bahi-Buisson, N; Brailly-Tabard, S; Célestin, E; Charles, P; Durand, E; Fontaine, I; Lambert, AS; Linglart, A; Miladi, L; Rothenbuhler, A; Trabado, S; Wicart, P, 2017)
"Treatment with pamidronate is beneficial for the patient, family and society, increases mobility and bone density, improves quality of life and reduces family dependence in children with OI."	1.46	Therapy with pamidronate in children with osteogenesis imperfecta. ( Brad, GF; Mang, N; Marginean, O; Mozos, I; Tamasanu, RC, 2017)
"Pamidronate was administered in three-day cycles."	1.42	Beneficial effects of intravenous pamidronate treatment in children with osteogenesis imperfecta under 24 months of age. ( Ayoob, R; Bowden, SA; Ingraham, S; Kusumi, K; Mahan, JD, 2015)
" However, clinical efficacy and optimal dosing in non-OI patients has not been established."	1.37	Treatment of symptomatic osteoporosis in children: a comparison of two pamidronate dosage regimens. ( Huang, C; Martinez-Soto, T; Pacaud, D; Stephure, D; Trussell, R, 2011)
"McCune-Albright syndrome (MAS) typically comprises the constellation of polyostotic fibrous dysplasia, café-au-lait spots, and associated endocrinopathies including gonadotropin-independent precocious puberty, excessive growth hormone production and gigantism, hyperthyroidism, and hyperparathyroidism."	1.36	Unusual phenotypical variations in a boy with McCune-Albright syndrome. ( Anhalt, H; Mamkin, I; Philibert, P; Sultan, C; Ten, S, 2010)
"Hypercalcemia is rare and when it is diagnosed, primary hyperparathyroidism should be ruled out."	1.35	[Paget's disease and hypercalcemia: coincidence or causal relationship?]. ( Altman, A; Green, I, 2009)
"In total, 55,864 women with breast cancer were included, with 307,467 person-years of follow-up."	1.35	Use of intravenous bisphosphonates in older women with breast cancer. ( Duan, Z; Fang, S; Giordano, SH; Goodwin, JS; Hortobagyi, GN; Kuo, YF, 2008)
"The pamidronate dose was increased to 60 mg once a week and was well tolerated."	1.32	Pamidronate in a girl with chronic renal insufficiency dependent on parenteral nutrition. ( Chesney, RW; Duke, JL; Frizzell, NK; Hak, EB; Jones, DP, 2003)
"The total number of new bone fractures and total number of patients with new fractures were less frequent during the pamidronate treatment period than before (p < 0."	1.30	[Extended use, up to 6 years, of an oral amino-bisphosphonate in patients with established osteoporosis]. ( Bogado, C; Plotkin, H; Roldán, EJ; Sarli, M; Spivacow, RF; Zanchetta, JR, 1997)
"With respect to markers of bone resorption, urinary deoxypyridinoline fell by 51% +/- 9% in group A patients and increased by 65% +/- 22% in group B patients by 3 months after transplantation (P < ."	1.30	Prevention of bone loss after heart transplantation with antiresorptive therapy: a pilot study. ( Addesso, V; Lo, SH; Mancini, D; McMahon, DJ; Michler, RE; Rodino, MA; Seibel, MJ; Shane, E; Staron, RB, 1998)

Research

Studies (88)

Authors

Clinical Trials (5)

Trial Overview

Trial Outcomes

Number of Participants With New Morphometric Vertebral Fractures During the 12 Month Extension Period by Core Treatment Group.

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	12 (13.64)	18.2507
2000's	47 (53.41)	29.6817
2010's	26 (29.55)	24.3611
2020's	3 (3.41)	2.80

Authors	Studies
Jeffery, TC	1
Chang, AB	1
Conwell, LS	1
Bhardwaj, A	1
Swe, KMM	1
Sinha, NK	1
Erbaş, İM	1
İlgün Gürel, D	1
Manav Kabayeğit, Z	1
Koç, A	1
Ünüvar, T	1
Abacı, A	1
Böber, E	1
Anık, A	1
Marginean, O	1
Tamasanu, RC	1
Mang, N	1
Mozos, I	1
Brad, GF	1
Lambert, AS	1
Rothenbuhler, A	1
Charles, P	1
Brailly-Tabard, S	1
Trabado, S	1
Célestin, E	1
Durand, E	1
Fontaine, I	1
Miladi, L	1
Wicart, P	1
Bahi-Buisson, N	1
Linglart, A	1
Mhaskar, R	2
Kumar, A	2
Miladinovic, B	2
Djulbegovic, B	2
Baroncelli, GI	1
Vierucci, F	1
Bertelloni, S	1
Erba, P	1
Zampollo, E	1
Giuca, MR	1
Terpos, E	1
Morgan, G	1
Dimopoulos, MA	2
Drake, MT	1
Lentzsch, S	1
Raje, N	1
Sezer, O	1
García-Sanz, R	1
Shimizu, K	1
Turesson, I	2
Reiman, T	1
Jurczyszyn, A	1
Merlini, G	1
Spencer, A	1
Leleu, X	1
Cavo, M	1
Munshi, N	1
Rajkumar, SV	1
Durie, BG	1
Roodman, GD	1
Alcausin, MB	1
Briody, J	1
Pacey, V	1
Ault, J	1
McQuade, M	1
Bridge, C	1
Engelbert, RH	1
Sillence, DO	1
Munns, CF	1
Lin, CH	1
Chien, YH	1
Peng, SF	1
Tsai, WY	1
Tung, YC	1
Lee, CT	1
Chien, CC	1
Hwu, WL	1
Lee, NC	1
Choi, Y	1
Yi, NJ	1
Ko, JS	1
Ko, JM	1
Jin, US	1
Kim, HS	1
Lee, KH	1
Cho, TJ	1
Suh, SW	1
Yoo, T	1
Lee, KW	1
Suh, KS	1
Atta, I	1
Iqbal, F	1
Lone, SW	1
Ibrahim, M	1
Khan, YN	1
Raza, J	1
Kusumi, K	1
Ayoob, R	1
Bowden, SA	1
Ingraham, S	1
Mahan, JD	1
Sinikumpu, JJ	1
Ojaniemi, M	1
Lehenkari, P	1
Serlo, W	1
Palomo, T	1
Andrade, MC	1
Peters, BS	1
Reis, FA	1
Carvalhaes, JT	1
Glorieux, FH	6
Rauch, F	5
Lazaretti-Castro, M	3
Zyma, AM	1
Guk, YM	1
Magomedov, OM	1
Gayko, OG	1
Kincha-Polishchuk, TA	1
Lindahl, K	1
Kindmark, A	1
Rubin, CJ	1
Malmgren, B	1
Grigelioniene, G	1
Söderhäll, S	1
Ljunggren, Ö	1
Åström, E	1
Veszelyné Kotán, E	1
Mészaros, Á	1
Giordano, SH	1
Fang, S	1
Duan, Z	1
Kuo, YF	1
Hortobagyi, GN	2
Goodwin, JS	1
Barros, ER	2
Dias da Silva, MR	1
Kunii, IS	1
Alharbi, M	1
Pinto, G	1
Finidori, G	1
Souberbielle, JC	1
Guillou, F	1
Gaubicher, S	1
Le Merrer, M	1
Polak, M	1
Cheung, MS	1
Geusens, P	1
Brown, JJ	1
Zacharin, MR	1
Hasegawa, K	1
Inoue, M	1
Seino, Y	1
Morishima, T	1
Tanaka, H	1
Santos, C	1
Arnal, C	1
Bhadada, SK	1
Santosh, R	1
Bhansali, A	1
Upreti, V	1
Dutta, P	1
Crawford, BS	1
McNulty, RM	1
Kraut, EH	1
Turowski, RC	1
Green, I	1
Altman, A	1
Mamkin, I	1
Philibert, P	1
Anhalt, H	1
Ten, S	1
Sultan, C	1
Shapiro, JR	1
Thompson, CB	1
Wu, Y	1
Nunes, M	1
Gillen, C	1
Bachrach, SJ	2
Kecskemethy, HH	2
Harcke, HT	2
Hossain, J	1
Arundel, P	1
Offiah, A	1
Bishop, NJ	3
Ludwig, H	1
Zojer, N	1
Kaur, S	1
Kulkarni, KP	1
Kochar, IS	1
Narasimhan, R	1
Boyce, AM	1
Gafni, RI	1
Martinez-Soto, T	1
Pacaud, D	1
Stephure, D	1
Trussell, R	1
Huang, C	1
Redzepovic, J	1
Wheatley, K	1
Clark, OA	1
Glasmacher, A	1
Saraiva, GL	1
de Oliveira, TP	1
Matarazzo, P	1
Lala, R	1
Masi, G	1
Andreo, M	1
Altare, F	1
de Sanctis, C	1
Giraud, F	1
Meunier, PJ	1
Dodidou, P	1
Bruckner, T	1
Hosch, S	1
Haass, M	1
Klar, E	1
Sauer, P	1
Ziegler, R	1
Leidig-Bruckner, G	1
Falk, MJ	1
Heeger, S	1
Lynch, KA	1
DeCaro, KR	1
Bohach, D	1
Gibson, KS	1
Warman, ML	1
Steelman, J	1
Zeitler, P	1
Diab, M	1
Raff, M	1
Gunther, DF	1
Duke, JL	1
Jones, DP	1
Frizzell, NK	1
Chesney, RW	1
Hak, EB	1
Rosen, LS	1
Gordon, DH	1
Dugan, W	1
Major, P	2
Eisenberg, PD	1
Provencher, L	1
Kaminski, M	1
Simeone, J	2
Seaman, J	3
Chen, BL	1
Coleman, RE	2
Tralongo, P	1
Repetto, L	1
Di Mari, A	1
Mauceri, G	1
Bollina, R	1
Ferrau', F	1
Conti, G	1
DiMeglio, LA	2
Ford, L	1
McClintock, C	1
Peacock, M	2
Popko, J	1
Galicka, A	1
Wołczyński, S	1
Zalewski, W	1
Konstantynowicz, J	1
Tanvetyanon, T	1
Grissom, LE	1
McKay, C	1
Letocha, AD	1
Cintas, HL	1
Troendle, JF	1
Reynolds, JC	1
Cann, CE	1
Chernoff, EJ	1
Hill, SC	1
Gerber, LH	1
Marini, JC	1
Forin, V	1
Arabi, A	1
Guigonis, V	1
Filipe, G	1
Bensman, A	1
Roux, C	1
Munns, C	1
Land, C	2
el-Sobky, MA	1
Hanna, AA	1
Basha, NE	1
Tarraf, YN	1
Said, MH	1
Bayram, F	1
Tanriverdi, F	1
Kurtoğlu, S	1
Atabek, ME	1
Kula, M	1
Kaynar, L	1
Keleştimur, F	1
Henderson, R	1
Plotkin, H	4
Coughlin, S	1
Kreikemeier, R	1
Heldt, K	1
Bruzoni, M	1
Lerner, G	1
Travers, R	3
Ward, KA	1
Adams, JE	1
Freemont, TJ	1
Mughal, MZ	1
Lipton, A	3
Cook, RJ	1
Smith, MR	1
Yamada, K	1
Kohno, N	1
Akcay, T	1
Turan, S	1
Guran, T	1
Bereket, A	1
Chapurlat, RD	1
Orcel, P	1
Andiran, N	1
Alikasifoglu, A	1
Gonc, N	1
Ozon, A	1
Kandemir, N	1
Yordam, N	1
Berenson, JR	1
Lichtenstein, A	1
Porter, L	2
Bordoni, R	1
George, S	1
Keller, A	1
Ballester, O	1
Kovacs, MJ	1
Blacklock, HA	1
Bell, R	1
Reitsma, DJ	1
Heffernan, M	1
Knight, RD	2
Kanis, JA	2
Paterson, AH	1
Powles, TJ	1
McCloskey, E	1
Hanson, J	1
Ashley, S	1
Delmas, PD	1
Theriault, RL	1
Blayney, D	1
Sinoff, C	1
Wheeler, H	1
Simeone, JF	1
Licata, AA	1
Kodama, H	1
Kubota, K	1
Abe, T	1
Man, Z	1
Otero, AB	1
Zanchetta, JR	1
Spivacow, RF	1
Bogado, C	1
Sarli, M	1
Roldán, EJ	1
Brincker, H	1
Westin, J	1
Abildgaard, N	1
Gimsing, P	1
Hedenus, M	1
Ford, J	1
Kandra, A	1
Chabot, G	1
Lanoue, G	1
Shane, E	1
Rodino, MA	1
McMahon, DJ	1
Addesso, V	1
Staron, RB	1
Seibel, MJ	1
Mancini, D	1
Michler, RE	1
Lo, SH	1
Paule, B	1
Clerc, D	1
Brion, N	1
Montpetit, K	1
Ruck-Gibis, J	1
Zacharin, M	2
O'Sullivan, M	1
Cundy, T	1
Watts, NB	1
González, E	1
Pavía, C	1
Ros, J	1
Villaronga, M	1
Valls, C	1
Escolá, J	1
Cahill, BC	1
O'Rourke, MK	1
Parker, S	1
Stringham, JC	1
Karwande, SV	1
Knecht, TP	1
Lee, YS	1
Low, SL	1
Lim, LA	1
Loke, KY	1
Groff, L	1
Zecca, E	1
De Conno, F	1
Brunelli, C	1
Boffi, R	1
Panzeri, C	1
Cazzaniga, M	1
Ripamonti, C	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation[NCT02074631]	Phase 2	80 participants (Actual)	Interventional	2015-02-28	Completed
A Phase I Pilot Trial to Study the Safety and Efficacy of Concomitant Radiotherapy and Zoledronic Acid for the Palliation of Bone Metastases From Breast Cancer, Prostate Cancer and Lung Cancer[NCT00264420]	Phase 1	4 participants (Actual)	Interventional	2005-12-31	Completed
Bone Biopsy for Histomorphometry and Analysis of Bone Marrow Derived Osteoblast and Osteoclast Progenitors to Explore Mechanisms of Decreased Bone Mineral Density in Depression[NCT00001916]		17 participants	Observational	1999-03-31	Completed
Osteoporosis in Cystic Fibrosis: Study of Bone Mass and Bone Metabolism, and Prospective Randomized Therapeutic Trial.[NCT01812551]	Phase 3	171 participants (Actual)	Interventional	2002-10-31	Completed
A 1-year, Multicenter, Open-label Extension to CZOL446H2337 to Evaluate Safety and Efficacy of Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids[NCT01197300]	Phase 3	25 participants (Actual)	Interventional	2010-10-25	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Vertebral morphometry (or concave index) was calculated using the average ratio between mid-height and posterior height from L1 to L4 and performed by a central reader. A new morphometric vertebral fractures during the 12 month Extension Period was defined as a morphometric vertebral fracture present at Month 24 X-ray which was not present at the Extension Baseline (Baseline 2). (NCT01197300)
Timeframe: Month 24 (Visit 15/Final Extension Visit)

Number of Participants With New Vertebral Fractures During the 12 Month Extension Period by Core Treatment Group.

Intervention	Participants (Count of Participants)
Core Treatment Zoledronic Acid	1
Core Treatment: Placebo	1

New vertebral fractures are defined as fractures of Genant grade 1 or higher that occur at lumbar or thoracic spine from first extension dose infusion to the end of the study in a previously normal vertebra. (NCT01197300)
Timeframe: Month 24 (Visit 15/Final Extension Visit)

Long-term Safety of Zoledronic Acid for the Treatment of Osteoporotic Children Treated With Glucocorticoids.

Intervention	Participants (Count of Participants)
Core Treatment Zoledronic Acid	1
Core Treatment: Placebo	1

Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that zoledronic acid given long-term, over an additional 12 months from the Core study (CZOL446H2337), is safe for the treatment of osteoporotic children treated with glucocorticoids through the monitoring of relevant clinical and laboratory safety parameters. (NCT01197300)
Timeframe: Baseline 1 (Visit 1 of the Core Study) through Month 24 (Visit 15/Final Extension Visit)

Mean Change From Baseline (Core and Extension) in 2nd Metacarpal Cortical Width at Month 24 by Core Treatment Group.

Intervention	Participants (Count of Participants)
	On-treatment Adverse Events (AEs)	On-treatment Serious Adverse Events (SAEs)	On-treatment Deaths
Core Treatment Zoledronic Acid	7	3	0
Core Treatment: Placebo	12	0	0

Left postero-anterior (PA) hand/wrist X-ray were taken at the final visit of Core study and at Visit 15/EOS (Month 24) to assess bone age. The change in 2nd metacarpal cortical width at Month 24 relative to the respective Baseline was calculated. If a fracture of the left upper extremity precluded radiographic imaging, (or precluded this X-ray in the Core study) then the right hand was evaluated for this purpose. In this case, an image of the right hand was carried out at both Visit 8 and at Visit 15/EOS (Month 24). The information was used in the assessment of bone density. (NCT01197300)
Timeframe: Baseline 1 (Visit 1 of the Core Study) and Baseline 2 (Visit 9 of the Extension Study) through Month 24 (Visit 15/Final Extension Visit)

Mean Change From Baseline 1 (Visit 1 of the Core Study) in BSAP at Month 18 and 24 by Core Treatment Group.

Intervention	millimeter (mm) (Least Squares Mean)
	2nd metacarpal cortical width change from BL1	2nd metacarpal cortical width change from BL2
Core Treatment Zoledronic Acid	-0.04	-0.09
Core Treatment: Placebo	-0.03	0.02

Bone specific alkaline phosphatase (BSAP) was collected at the final visit Core study at Visit 8, or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension study Visit/EOS) of Extension study according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy. (NCT01197300)
Timeframe: Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)

Mean Change From Baseline 1 (Visit 1 of the Core Study) in Lumbar Spine Bone Mineral Content (BMC) at Month 18 and 24 by Core Treatment Group.

Intervention	nanogram per milliliter (ng/mL) (Least Squares Mean)
	BSAP Change at Month 18	BSAP Change at Month 24
Core Treatment Zoledronic Acid	-13.716	-9.675
Core Treatment: Placebo	3.975	-6.013

Lumbar Spine Bone Mineral Content (BMC) was determined by the central imaging vendor at the final visit of Core study (Visit 8) or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension Study visit/EOS) of Extension study. The methods to be used to measure BMC were described in the respective DXA Manuals. Positive changes from Core baseline indicated an improvement in condition. (NCT01197300)
Timeframe: Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)

Mean Change From Baseline 1 (Visit 1 of the Core Study) in Lumbar Spine Bone Mineral Density (BMD) Z-score at Month 18 and 24 by Core Treatment Group.

Intervention	gram (Least Squares Mean)
	Lumbar Spine BMC Change at Month 18	Lumbar Spine BMC Change at Month 24
Core Treatment Zoledronic Acid	12.293	15.845
Core Treatment: Placebo	9.933	14.666

Lumbar Spine Bone Mineral Density (BMD) Z-score was determined by the central imaging vendor at the final visit of Core study (Visit 8) or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension Study visit/EOS) of Extension study. The methods to be used to measure Lumbar Spine BMD Z-score were described in the respective DXA Manuals provided by central imaging vendor. Positive changes from Core baseline indicated an improvement in condition. (NCT01197300)
Timeframe: Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)

Mean Change From Baseline 1 (Visit 1 of the Core Study) in Serum NTX at Month 18 and 24 by Core Treatment Group.

Intervention	Z-score (Least Squares Mean)
	Lumbar Spine BMD Z-score Change at Month 18	Lumbar Spine BMD Z-score Change at Month 24
Core Treatment Zoledronic Acid	-40.648	-46.161
Core Treatment: Placebo	-44.348	-67.913

Serum Cross linked N-telopeptide (NTX) was collected at the final visit Core study at Visit 8, or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension study Visit/EOS) of Extension study according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy. (NCT01197300)
Timeframe: Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)

Mean Change From Baseline 1 (Visit 1 of the Core Study) in Serum P1NP at Month 18 and 24 by Core Treatment Group.

Intervention	nmol BCE/L (Least Squares Mean)
	Serum NTX Change at Month 18	Serum NTX Change at Month 24
Core Treatment Zoledronic Acid	-17.577	-17.450
Core Treatment: Placebo	-12.916	-14.891

Serum Procollagen type 1 amino-terminal propeptide (P1NP) was collected at the final visit Core study at Visit 8, or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension study Visit/EOS) of Extension study according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy. (NCT01197300)
Timeframe: Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)

Mean Change From Baseline 1 (Visit 1 of the Core Study) in Serum TRAP-5b at Month 18 and 24 by Core Treatment Group.

Intervention	nanogram per milliliter (ng/mL) (Least Squares Mean)
	Serum P1NP Change at Month 18	Serum P1NP Change at Month 24
Core Treatment Zoledronic Acid	-169.837	-228.068
Core Treatment: Placebo	-22.157	-95.631

Serum Tartrate-resistant acid phosphatase isoform 5b (TRAP 5b) were collected at the final visit Core study at Visit 8, or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension study Visit/EOS) of Extension study according to the instructions provided in the Laboratory Manual. The samples were analyzed in batches at the laboratory. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy. Decrease or negative changes from Core baseline indicated a pharmacological response to therapy. (NCT01197300)
Timeframe: Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)

Mean Change From Baseline 1 (Visit 1 of the Core Study) in Total Body BMC at Month 18 and 24 by Core Treatment Group.

Intervention	U/L (Least Squares Mean)
	Serum TRAP-5b Change at Month 18	Serum TRAP-5b Change at Month 24
Core Treatment Zoledronic Acid	-2.661	-2.670
Core Treatment: Placebo	-1.179	-2.260

Total body BMC were determined by the central imaging vendor at the final visit of Core study (Visit 8) or at 1st infusion visit (Visit 9), and thereafter at Visit 12 (Month 18) and Visit 15 (Month 24) (final Extension Study visit/EOS) of Extension study. The methods to be used to measure BMC were described in the respective DXA Manuals. Positive changes from Core baseline indicated an improvement in condition. (NCT01197300)
Timeframe: Month 18 (Visit 12 of the Extension Study), Month 24 (Visit 15/Final Extension Visit)

Percentage of Patients With Reduction in Pain From Baseline 1 (Visit 1 of the Core Study) at Month 15, 18, 21 and 24 by Core Treatment Group.

Intervention	gram (Least Squares Mean)
	Total body BMC Change at Month 18	Total body BMC Change at Month 24
Core Treatment Zoledronic Acid	387.721	496.997
Core Treatment: Placebo	266.592	431.323

Pain was evaluated at each visit (at office and telephone visit) at the final visit of the Core study and first visit of the Extension study (Visit 9), Visits 11 (Month 15), 12 (Month 18), 14 (Month 21) and 15 (Month 24) using the Faces Pain Scale-Revised (FPS-R). Children were selecting the face that best fits their pain. The pain score ranged from 0 (No Pain) to 10 (Very Much Pain). The reduction in pain from Core baseline by visit was evaluated based on whether or not patients had a decrease in their FPS-R from baseline. If pain remained the same or worsened from baseline a patient was classified as '0' and if the pain scale decreased then the patient was classified as '1'. (NCT01197300)
Timeframe: Month 15, Month 18, Month 21, Month 24

Intervention	Percentage of Patients (Number)
	Reduction in Pain at Month 15	Reduction in Pain at Month 18	Reduction in Pain at Month 21	Reduction in Pain at Month 24
Core Treatment Zoledronic Acid	55.6	30.0	30.0	30.0
Core Treatment: Placebo	46.2	50.0	50.0	38.5

Article	Year
Clinical, genetic characteristics and treatment outcomes of children and adolescents with osteogenesis imperfecta: a two-center experience. Connective tissue research, 2022, Volume: 63, Issue:4 Topics: Adolescent; Child; Child, Preschool; Collagen Type I; Connective Tissue Diseases; Female; Fractures,	2022
Therapy with pamidronate in children with osteogenesis imperfecta. Drug design, development and therapy, 2017, Volume: 11 Topics: Adolescent; Alkaline Phosphatase; Bone Density; Bone Density Conservation Agents; Child; Child, Pres	2017
Lower incidence of fracture after IV bisphosphonates in girls with Rett syndrome and severe bone fragility. PloS one, 2017, Volume: 12, Issue:10 Topics: Adolescent; Adult; Bone Density; Bone Density Conservation Agents; Calcium; Child; Creatinine; Dipho	2017
International Myeloma Working Group recommendations for the treatment of multiple myeloma-related bone disease. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013, Jun-20, Volume: 31, Issue:18 Topics: Administration, Intravenous; Bone Density Conservation Agents; Bone Diseases; Clodronic Acid; Combin	2013
Intravenous pamidronate treatment in children with moderate-to-severe osteogenesis imperfecta started under three years of age. Hormone research in paediatrics, 2013, Volume: 79, Issue:6 Topics: Bone Density; Bone Density Conservation Agents; Child, Preschool; Diphosphonates; Female; Fractures,	2013
Cyclic pamidronate infusion for neonatal-onset osteogenesis imperfecta. Pediatrics and neonatology, 2014, Volume: 55, Issue:4 Topics: Bone Density; Child; Child, Preschool; Diphosphonates; Drug Administration Schedule; Female; Fractur	2014
Living donor liver transplantation for an infant with osteogenesis imperfecta and intrahepatic cholestasis: report of a case. Journal of Korean medical science, 2014, Volume: 29, Issue:3 Topics: Bone Density; Bone Density Conservation Agents; Cholestasis, Intrahepatic; Diphosphonates; Fractures	2014
Effect of intravenous pamidronate treatment in children with osteogenesis imperfecta. Journal of the College of Physicians and Surgeons--Pakistan : JCPSP, 2014, Volume: 24, Issue:9 Topics: Absorptiometry, Photon; Administration, Intravenous; Administration, Oral; Adolescent; Bone Density;	2014
Beneficial effects of intravenous pamidronate treatment in children with osteogenesis imperfecta under 24 months of age. Journal of bone and mineral metabolism, 2015, Volume: 33, Issue:5 Topics: Administration, Intravenous; Adolescent; Adult; Bone Density; Bone Density Conservation Agents; Chil	2015
[PREPARATIONS OF PAMIDRONOVIC ACID IN COMPLEX TREATMENT ON OSTEOGENESIS IMPERFECTA]. Klinichna khirurhiia, 2015, Issue:7 Topics: Bone and Bones; Bone Density; Bone Density Conservation Agents; Calcium; Child; Child, Preschool; Di	2015
Decreased fracture rate, pharmacogenetics and BMD response in 79 Swedish children with osteogenesis imperfecta types I, III and IV treated with Pamidronate. Bone, 2016, Volume: 87 Topics: Body Height; Bone Density; Child; Child, Preschool; Collagen Type I; Diphosphonates; DNA Mutational	2016
Use of intravenous bisphosphonates in older women with breast cancer. The oncologist, 2008, Volume: 13, Issue:5 Topics: Age Factors; Aged; Aged, 80 and over; Bone Density Conservation Agents; Bone Neoplasms; Breast Neopl	2008
Three years follow-up of pamidronate therapy in two brothers with osteoporosis-pseudoglioma syndrome (OPPG) carrying an LRP5 mutation. Journal of pediatric endocrinology & metabolism : JPEM, 2008, Volume: 21, Issue:8 Topics: Antineoplastic Agents; Blindness; Bone Density; Bone Density Conservation Agents; Child; Child, Pres	2008
Pamidronate treatment of children with moderate-to-severe osteogenesis imperfecta: a note of caution. Hormone research, 2009, Volume: 71, Issue:1 Topics: Absorptiometry, Photon; Amino Acids; Bone Density; Bone Density Conservation Agents; Child; Child, P	2009
Intravenous pamidronate in osteogenesis imperfecta type VII. Calcified tissue international, 2009, Volume: 84, Issue:3 Topics: Adolescent; Blood Chemical Analysis; Bone and Bones; Bone Density; Bone Density Conservation Agents;	2009
Growth of infants with osteogenesis imperfecta treated with bisphosphonate. Pediatrics international : official journal of the Japan Pediatric Society, 2009, Volume: 51, Issue:1 Topics: Bone Density Conservation Agents; Child, Preschool; Diphosphonates; Fractures, Bone; Growth; Humans;	2009
[Stop in bone remodeling in imperfect osteogenesis]. Medicina clinica, 2010, Apr-10, Volume: 134, Issue:10 Topics: Anti-Inflammatory Agents; Bone Density Conservation Agents; Bone Remodeling; Child; Diphosphonates;	2010
Osteogenesis imperfecta. The Journal of the Association of Physicians of India, 2009, Volume: 57 Topics: Adolescent; Adult; Bone Density; Bone Density Conservation Agents; Child; Child, Preschool; Diphosph	2009
Extended use of intravenous bisphosphonate therapy for the prevention of skeletal complications in patients with cancer. Cancer investigation, 2009, Volume: 27, Issue:10 Topics: Adult; Aged; Aged, 80 and over; Bone Density Conservation Agents; Bone Neoplasms; Breast Neoplasms;	2009
[Paget's disease and hypercalcemia: coincidence or causal relationship?]. Harefuah, 2009, Volume: 148, Issue:10 Topics: Aged; Anti-Inflammatory Agents; Diphosphonates; Female; Fractures, Bone; Humans; Hypercalcemia; Oste	2009
Unusual phenotypical variations in a boy with McCune-Albright syndrome. Hormone research in paediatrics, 2010, Volume: 73, Issue:3 Topics: Base Sequence; Child; Diphosphonates; Fibrous Dysplasia, Polyostotic; Fractures, Bone; Growth Disord	2010
Decreased fracture incidence after 1 year of pamidronate treatment in children with spastic quadriplegic cerebral palsy. Developmental medicine and child neurology, 2010, Volume: 52, Issue:9 Topics: Adolescent; Age Factors; Bone Density; Bone Density Conservation Agents; Cerebral Palsy; Child; Chil	2010
Evolution of the radiographic appearance of the metaphyses over the first year of life in type V osteogenesis imperfecta: clues to pathogenesis. Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2011, Volume: 26, Issue:4 Topics: Arm Bones; Bone Density Conservation Agents; Bone Diseases, Metabolic; Cranial Fontanelles; Diphosph	2011
Management of lower limb deformities in children with osteogenesis imperfecta. Indian pediatrics, 2011, Volume: 48, Issue:8 Topics: Calcium; Child; Diphosphonates; Fractures, Bone; Humans; Lower Extremity; Male; Osteogenesis Imperfe	2011
Approach to the child with fractures. The Journal of clinical endocrinology and metabolism, 2011, Volume: 96, Issue:7 Topics: Absorptiometry, Photon; Bone Density; Bone Density Conservation Agents; Child; Diphosphonates; Femal	2011
Treatment of symptomatic osteoporosis in children: a comparison of two pamidronate dosage regimens. Journal of pediatric endocrinology & metabolism : JPEM, 2011, Volume: 24, Issue:5-6 Topics: Adolescent; Bone Density; Bone Density Conservation Agents; Child; Diphosphonates; Dose-Response Rel	2011
Treatment of symptomatic pediatric osteoporosis with cyclic single-day intravenous pamidronate infusions. The Journal of pediatrics, 2003, Volume: 142, Issue:4 Topics: Adolescent; Adult; Age Factors; Anti-Inflammatory Agents; Bone Density; Child; Diphosphonates; Drug	2003
Osseous fragility in Marshall-Smith syndrome. American journal of medical genetics. Part A, 2003, Jun-01, Volume: 119A, Issue:2 Topics: Age Determination by Skeleton; Antineoplastic Agents; Bone and Bones; Bone Diseases, Developmental;	2003
Pamidronate in a girl with chronic renal insufficiency dependent on parenteral nutrition. Pediatric nephrology (Berlin, Germany), 2003, Volume: 18, Issue:7 Topics: Anti-Inflammatory Agents; Calcitonin; Child; Chlorothiazide; Colonic Diseases; Diphosphonates; Diure	2003
Safety of long-term administration of bisphosphonates in elderly cancer patients. Oncology, 2004, Volume: 67, Issue:2 Topics: Aged; Antineoplastic Agents; Bone Neoplasms; Breast Neoplasms; Diphosphonates; Drug Administration S	2004
[Osteogenesis imperfecta as an interdisciplinary medical problem]. Chirurgia narzadow ruchu i ortopedia polska, 2004, Volume: 69, Issue:4 Topics: Absorptiometry, Photon; Adolescent; Anti-Inflammatory Agents; Child; Child, Preschool; Collagen; Dip	2004
Re: Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. Journal of the National Cancer Institute, 2005, Jan-05, Volume: 97, Issue:1 Topics: Analgesics; Antineoplastic Agents; Bone Neoplasms; Diphosphonates; Fractures, Bone; Humans; Imidazol	2005
Bone densitometry in pediatric patients treated with pamidronate. Pediatric radiology, 2005, Volume: 35, Issue:5 Topics: Absorptiometry, Photon; Adolescent; Adult; Bone Density; Cerebral Palsy; Child; Child, Preschool; Di	2005
Benefits of pamidronate in children with osteogenesis imperfecta: an open prospective study. Joint bone spine, 2005, Volume: 72, Issue:4 Topics: Adolescent; Alkaline Phosphatase; Anti-Inflammatory Agents; Bone Density; Child; Child, Preschool; C	2005
Surgery versus surgery plus pamidronate in the management of osteogenesis imperfecta patients: a comparative study. Journal of pediatric orthopedics. Part B, 2006, Volume: 15, Issue:3 Topics: Adolescent; Bone Density; Bone Density Conservation Agents; Child; Child, Preschool; Combined Modali	2006
Effects of 3 years of intravenous pamidronate treatment on bone markers and bone mineral density in a patient with osteoporosis-pseudoglioma syndrome (OPPG). Journal of pediatric endocrinology & metabolism : JPEM, 2006, Volume: 19, Issue:3 Topics: Abnormalities, Multiple; Adolescent; Adult; Bone Density; Bone Density Conservation Agents; Central	2006
Low doses of pamidronate for the treatment of osteopenia in non-ambulatory children. Developmental medicine and child neurology, 2006, Volume: 48, Issue:9 Topics: Bone Density; Bone Density Conservation Agents; Bone Diseases, Metabolic; Cerebral Palsy; Child; Chi	2006
Can bisphosphonate treatment be stopped in a growing child with skeletal fragility? Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2007, Volume: 18, Issue:8 Topics: Accidental Falls; Bone Density; Bone Density Conservation Agents; Child, Preschool; Diphosphonates;	2007
Alendronate treatment in children with osteogenesis imperfecta. Indian pediatrics, 2008, Volume: 45, Issue:2 Topics: Adolescent; Bone Density; Bone Density Conservation Agents; Calcium; Child; Child, Preschool; Diphos	2008
Role of bisphosphonates in prevention and treatment of bone metastases from breast cancer. The Canadian journal of oncology, 1995, Volume: 5 Suppl 1 Topics: Analgesics, Non-Narcotic; Antineoplastic Agents; Bone Neoplasms; Breast Neoplasms; Clodronic Acid; D	1995
Bisphosphonates in the treatment of bone diseases. The New England journal of medicine, 1996, Dec-12, Volume: 335, Issue:24 Topics: Bone Neoplasms; Bone Resorption; Breast Neoplasms; Diphosphonates; Disease-Free Survival; Female; Fr	1996
Osteogenesis imperfecta: Are fractures and growth hormone treatment linked? The Journal of pediatrics, 1998, Volume: 132, Issue:3 Pt 1 Topics: Child; Diphosphonates; Drug Therapy, Combination; Female; Fractures, Bone; Human Growth Hormone; Hum	1998
[New spine and non-spine fractures in 871 women/year treated with oral pamidronate plus calcium and vitamin D supplements]. Medicina, 1997, Volume: 57 Suppl 1 Topics: Accidental Falls; Bone Density; Calcium, Dietary; Diphosphonates; Female; Follow-Up Studies; Fractur	1997
[Extended use, up to 6 years, of an oral amino-bisphosphonate in patients with established osteoporosis]. Medicina, 1997, Volume: 57 Suppl 1 Topics: Administration, Oral; Bone Density; Bone Resorption; Diphosphonates; Drug Tolerance; Female; Follow-	1997
Prevention of bone loss after heart transplantation with antiresorptive therapy: a pilot study. The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 1998, Volume: 17, Issue:11 Topics: Absorptiometry, Photon; Amino Acids; Biomarkers; Bone Density; Bone Resorption; Calcitriol; Calcium;	1998
[Biosphonates in oncology]. Presse medicale (Paris, France : 1983), 2000, Apr-08, Volume: 29, Issue:13 Topics: Bone Neoplasms; Clodronic Acid; Diphosphonates; Fractures, Bone; Humans; Neoplasms; Osteolysis; Pain	2000
Intravenous pamidronate treatment of polyostotic fibrous dysplasia associated with the McCune Albright syndrome. The Journal of pediatrics, 2000, Volume: 137, Issue:3 Topics: Adolescent; Adult; Bone and Bones; Bone Density; Cardiac Output; Child; Child, Preschool; Diphosphon	2000
Osteoporosis pseudoglioma syndrome: treatment of spinal osteoporosis with intravenous bisphosphonates. The Journal of pediatrics, 2000, Volume: 137, Issue:3 Topics: Analgesics, Non-Narcotic; Bone Density; Child; Clodronic Acid; Diphosphonates; Female; Fractures, Bo	2000
Efficacy of low dose schedule pamidronate infusion in children with osteogenesis imperfecta. Journal of pediatric endocrinology & metabolism : JPEM, 2001, Volume: 14, Issue:5 Topics: Absorptiometry, Photon; Bone Density; Child; Diphosphonates; Dose-Response Relationship, Drug; Femal	2001

pamidronate and Fractures, Bone