Background: Recombinant human parathyroid hormone (PTH [1-34]; teriparatide) is a new treatment for postmenopausal osteoporosis that can be systemically administered for the primary purpose of increasing bone formation Because several studies have described the enhancement of fracture-healing and o

Enhancement of Experimental Fracture-Healing by Systemic Administration of Recombinant Human Parathyroid Hormone (PTH 1-34)

Objective
Optimism and social support serve as protective factors against distress in medically ill patients. Very few studies have specifically explored the ways in which these variables interact to impact quality of life (QOL), particularly among patients with advanced cancer. The present study examined the role of optimism as a moderator of the relationship between social support and anxiety, depression, hopelessness, and QOL among patients with advanced cancer.

Optimism, social support, and mental health outcomes in patients with advanced cancer

IN NOVEMBER 2002, the Food and Drug Administration (FDA) approved teriparatide (Forteo) for the treatment of osteoporosis. Teriparatide contains the first 34 amino acids of human PTH. We will use the term teriparatide to describe PTH(1-34) produced by recombinant DNA technology by Eli Lilly & Co. (Indianapolis, IN, USA) and marketed as Forteo. The peptide produced by any other technology will be called PTH(1-34). The approval of teriparatide came after an eventful period of preclinical and clinical studies and was not without controversy. The approval process required the FDA to balance the potential oncologic risks with the clearly established benefits of this unique pharmacologic agent. This situation was created by preclinical data that showed the development of osteosarcomas in a high percentage of rodents treated with large doses of teriparatide for most of their lifespan. Aligned on the side advocating approval of teriparatide was the pharmaceutical maker (Eli Lilly & Co.), some patient groups representing those patients with severe osteoporosis, and a sizable component of basic and clinical investigators studying bone disease. Aligned against approval were several citizen watch groups who vigorously opposed human use of this agent because of concern regarding the potential development of osteosarcoma. Most vociferous was Public Citizen (www.publiccitizen.org), an organization actively opposed to use of this agent because of its potential carcinogenicity. The FDA had been under fire because of recalls of several previously approved pharmaceutical agents; the ensuing criticism created a tense regulatory environment. Perhaps the most interesting role was that of the metabolic bone disease community. After an initial period of surprise regarding the osteosarcoma data, researchers performing studies with teriparatide or other preparations of PTH(134) or PTH(1-84) examined their own patient populations treated with the hormone, and no reports of an association of osteosarcoma with PTH therapy have appeared. After a 1to 2-year period of sorting through their experiences, some extending to the mid-1980s, the reality set in that a novel pharmaceutical agent with shown effectiveness to stimulate new bone formation and little evidence of toxicity in humans might be disapproved. Furthermore, the absence of long-term patent protection for this agent created minimal incentive for the manufacturer to perform the longterm studies that would be necessary to prove safety in a definitive manner. Indeed, as events throughout the pharmaceutical industry have shown, the financial returns from the marketing of this agent (net revenue of $5.6 million in 2002, $56 million in 2003, and $239 million in 2004) would have to be balanced against the potential impact of litigation in the event that there was an adverse effect. More importantly, investigators in the field understood that disapproval of this agent would likely suppress future research using the PTH receptor system and its downstream signaling pathways as a pharmacologic target to stimulate bone formation. The prospect that research on the one signaling system that, at the time, was proven to increase bone formation and had no demonstrable toxicity in humans, was alarming to many basic and clinical researchers in the bone field and led to an advocacy role on behalf of teriparatide from a normally nonpolitical group once the company made a decision to move forward with a request for approval. The FDA chose a middle ground, one that permitted use of this agent for patients with severe forms of osteoporosis, accepting the time-tested tenet that the reduction in morbidity from the use of this agent in highrisk groups far outweighed the hypothetical risks. The FDA approved teriparatide for treatment of osteoporosis in men and women but placed significant limitations on its application. Use of the drug was limited to a 2-year period and exclusion of patients considered at high risk for osteosarcoma (those with a history of radiation exposure to bone, Paget’s disease of bone, and children with open epiphyses) and a recommendation that the pharmacologic agent be used only for those with substantial fracture risk. Despite these limitations, the decision was discussed broadly by experts in the bone community and was strongly supported by many academic and clinical investigators. In Dr Tashjian serves as a consultant for Eli Lilly and Company. Dr Gagel serves as a consultant for Proctor & Gamble, received speaker’s fee from Eli Lilly and Company, Merck, Novartis, Pfizer, and Proctor & Gamble, and received grants and research funding from Novartis and Pfizer.

Teriparatide [human PTH(1-34)]: 2.5 years of experience on the use and safety of the drug for the treatment of osteoporosis.

Head and Neck Cancer Survivorship: Learning the Needs, Meeting the Needs

Fracture healing is a complex process, and a significant number of fractures are complicated by impaired healing and non-union. Impaired healing is prevalent in certain risk groups, such as the elderly, osteoporotics, people with malnutrition, and women after menopause. Currently, no pharmacological treatments are available. There is therefore an unmet need for medications that can stimulate bone healing. Parathyroid hormone (PTH) is the first bone anabolic drug approved for the treatment of osteoporosis, and intriguingly a number of animal studies suggest that PTH could be beneficial in the treatment of fractures and could thus be a potentially new treatment option for induction of fracture healing in humans. Furthermore, fractures in animals with experimental conditions of impaired healing such as aging, estrogen withdrawal, and malnutrition can heal in an expedited manner after PTH treatment. Interestingly, fractures occurring at both cancellous and cortical sites can be treated successfully, indicating that both osteoporotic and nonosteoporotic fractures can be the target of PTH-induced healing. Finally, the data suggest that PTH partly prevents the delay in fracture healing caused by aging. Recently, the first randomized, controlled clinical trial investigating the effect of PTH on fracture healing was published, indicating a possible clinical benefit of PTH treatment in inducing fracture healing. The aim of this article is therefore to review the evidence for the potential of PTH in bone healing, including the underlying mechanisms for this, and to provide recommendations for the clinical testing and use of PTH in the treatment of impaired fracture healing in humans.

Parathyroid Hormone and Bone Healing

Effect of intermittent parathyroid hormone (1-34) treatment on the bone response after placement of titanium implants into the tibia of ovariectomized rats.

The purpose of this study was to investigate the action of hPTH (1-34) on bone reactions after placement of a titanium screw implant into the tibiae of ovariectomized rats. Twelve-week-old female Wistar rats were divided into 3 groups of 9 animals each. The first group (Sham) was sham-operated ; the second group (Ovx) was ovariectomized only, and the third group (PTH) was ovariectomized and received hPTH (1-34) at a dose of 30i/kg of body weight . Titanium screw implants were placed in the proximal metaphyses of the tibiae 168 days after surgery. The animals were sacrificed 7, 14, and 56 days after implantation. Undecalcified sections were prepared and evaluated by light microscopy. Ovariectomies reduced implant-bone contact and the bone volume around the implant. However, intermittent hPTH (1-34) administration can not only prevent resorption of newly generated trabeculae around the implant but also recover bone volume lost due to ovariectomy. These results suggested that intermittent hPTH (1-34) administration might be useful to facilitate postoperative bone formation, increasing the bone volume around the implant, and improving the clinical results.

https://www.jstage.jst.go.jp/article/jsotp1982/20/3/20_3_148/_pdf

Effects of intermittent parathyroid hormone (1-34) treatment on bone reaction around implants placed into the tibia of the ovariectomized rat

Objective: Although social support has been recognized as an important factor in the quality of life of head and neck cancer patients, there has been little investigation of the buffering effect of social support on these patients' social distress or of the coping skill of self-efficacy. The aim of this study was to examine how social support and self-efficacy mediate the relationship between social distress and emotional distress in head and neck cancer patients.

Methods: Two hundred twenty-five head and neck cancer patients completed our questionnaire (effective response rate, 92.2%). Of these, 129 (57.3%) had facial disfigurement. These participants responded to questions about perception of social distress, social support, self-efficacy, and emotional distress (depression and anxiety). We used structural equation modeling for statistical analysis.

Results: The fit indices of this model were excellent (χ2 (7) = 9.147, p = 0.242, goodness of fit index (GFI) = 0.981, adjusted goodness of fit index (AGFI) = 0.922, comparative fit index (CFI) = 0.993, root mean square error of approximation (RMSEA) = 0.049). Self-efficacy strongly buffered the negative influence of social distress on emotional distress. Social support from family members did not have a direct or indirect influence on emotional distress. Social support from friends was related to lower social distress and higher emotional distress.

Conclusions: Our findings suggest that self-efficacy might confound the relationship between social support and emotional distress, and that different sources of social support might play different roles in the mediation of social distress on emotional distress. Copyright © 2010 John Wiley & Sons, Ltd.

The mediating effects of social support and self‐efficacy on the relationship between social distress and emotional distress in head and neck cancer outpatients with facial disfigurement

Objective:This study assessed the factor structure, internal consistency, and concurrent and discriminant validity of a scale used to measure social distress in Japanese head and neck cancer outpatients with facial disfigurement.Method:The sample included 225 Japanese outpatients with head and neck cancer, including 129 patients with facial disfigurement. Participants' level of social distress was assessed through our scale, the European Organization for Research and Treatment Cancer questionnaire (EORTC) QLQ-H&N35 and the Hospital Anxiety and Depression scale (HADS).Results:Factor analyses confirmed the structure of two subscales of the social distress scale. Social distress was significantly correlated with the social contact subscale of the EORTC QLQ-H&N35 and the HADS.Significance of results:Results demonstrated preliminary reliability and validity of the social distress scale. This scale may extend social adjustment research by revealing its determinants and effects for head and neck cancer with facial disfigurement in Japan.

Developing the social distress scale for head and neck cancer outpatients in Japan.

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Effect of intermittent parathyroid hormone (1-34) treatment on the bone response after placement of titanium implants into the tibia of ovariectomized rats.

Effects of intermittent parathyroid hormone (1-34) treatment on bone reaction around implants placed into the tibia of the ovariectomized rat

The mediating effects of social support and self‐efficacy on the relationship between social distress and emotional distress in head and neck cancer outpatients with facial disfigurement

Developing the social distress scale for head and neck cancer outpatients in Japan.